Reusable Insulin Pen Injector — 60IU with 3ml Cartridge

Q: What is the minimum order quantity?

The standard MOQ is 100 pieces for stock configuration. Custom projects involving new colors, logo printing or private packaging start from 1,000 pieces — our sales team will confirm the exact figure with your quotation.

Q: Which cartridges and needles does this pen work with?

The pen accepts standard 3ml cartridges built to ISO 11608-3 and attaches to common pen needles compliant with ISO 11608-2. This covers most insulin, GLP-1 and growth hormone cartridge systems on the market.

Q: How many times can the pen be reused?

The device is rated for at least 3,000 injection cycles, which equals roughly 3 years of typical daily use. Only the cartridge and needle are replaced; the pen body itself is kept.

Q: How accurate is the dosing?

Dose delivery is tested to ISO 11608-1 with an error below 5% across the full 1–60IU range. Every production batch goes through sampling verification on dose accuracy, injection force and dial function.

Q: Does the pen come sterilized?

No. As a reusable device, the pen is supplied non-sterile and clean-packed. The sterile part of the system is the single-use pen needle, which must be replaced for every injection. The pen body can be wiped with a damp cloth for routine cleaning.

Q: Can you produce this pen under our own brand?

Yes. We customize body and cap colors, logo printing, dose scale units (IU, mg or ml), and retail packaging. Alternative dose ranges such as 80IU or GLP-1 mg scales are also available. Delivery is about 15 days after design approval.

Q: What certifications support this product?

Production runs in an ISO 13485:2016 certified facility. Our regulatory team can prepare technical documentation for CE (MDR), FDA registration and other market submissions based on your target region.

Q: How are the pens packed and shipped?

Each pen is packed in an individual color box with an instruction manual, then 100 boxes per export carton. We arrange express, air or sea freight to 50+ countries, with regular orders leaving the factory in about 15 days.

R&G Bio manufactures reusable pen injectors for insulin brands, pharmacies and medical distributors — accurate daily dosing in a durable, patient-friendly device.

A medical-grade mechanical core delivers precise dose increments up to 60IU with standard 3ml cartridges — smooth dialing, clear dose window and a robust metal body built for years of daily use.

Every unit is EO gas sterilized, batch-coded for full traceability, and produced in Class 100,000 cleanrooms under an ISO 13485 quality system. Review our certifications and compliance documents and see how we manufacture before you place a bulk order.

We support full OEM/ODM programs — custom specifications, private labeling and packaging built around your brand, with factory-direct MOQs and tiered wholesale pricing.

FDA Registered CE-RoHS ISO 13485 Sterile EO

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60IU Dose Range
3ml Standard Cartridge
Reusable Metal Body
ISO 13485 Factory
OEM/ODM Ready

KEY SPECIFICATIONS

Technical Specifications

Product Name	60IU Reusable Insulin Pen Injector with 3ml Cartridge & Durable Metal Lid
Device Type	Reusable, variable-dose mechanical pen injector (manual dial & push button)
Dose Range	0 – 60 IU (0 – 0.60 ml) per injection
Dose Increment	1 IU (0.01 ml) per click, two-way dial with dose correction
Dose Accuracy	Error < 5% across full range, tested to ISO 11608-1
Cartridge Capacity	Standard 3 ml cartridge (ISO 11608-3), replaceable
Needle Compatibility	Standard and safety pen needles (ISO 11608-2)
Cap / Lid	Durable metal lid — protects the pen during transport and daily carry
Body Materials	Medical-grade ABS / PC housing with precision metal drive components
Injection Force	Low injection force (< 30 N) for smooth, comfortable delivery
Service Life	≥ 3,000 injection cycles (approx. 3 years of typical use)
Applications	Insulin, GLP-1 analogues, growth hormone and other 3ml cartridge therapies
Production Standard	Manufactured in ISO 13485 certified facility, Class 100,000 cleanroom
Packaging	1 pc / color box with manual, 100 boxes / export carton
Unit Price	From US $4.90 / pc (volume-based)
MOQ	100 pcs

60 IU

Max Dose per Injection

1 IU

Precise Dose Increment

3 ml

Standard Cartridge Fit

3,000+

Injection Cycles Rated

MATERIALS & CRAFTSMANSHIP

Medical-Grade Materials, Reliable Mechanical Core

A pen injector lives in a patient’s hand every day, so material choice and assembly quality decide its real lifespan. From certified raw plastics to final function testing, every step is built for accuracy that lasts.

Engineered for Years of Daily Dosing

The pen body is molded from medical-grade ABS/PC that resists drops, scratches and daily cleaning. Inside, a high-precision screw drive with low-friction components keeps every 1IU step smooth and consistent. The metal lid shields the cartridge and needle mount, so the pen stays intact and functional even with rough handling or long transport.

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Durable Metal Lid

Protects the pen core from impact, dust and damage during carry and shipping.

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Precision Drive Mechanism

Injection-molded screw thread and high-lubrication parts deliver stable, low-force dosing.

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Clear Dose Display

Large, high-contrast dose window with audible and tactile clicks for confident setting and correction.

Built Inside an ISO 13485 Certified Factory

R&G BIO has manufactured medical-grade devices since 2009. Our 23,000 m² facility runs fully automated assembly lines inside Class 100,000 cleanrooms, with complete batch traceability from raw material to finished pen and a defect rate below 0.02%.

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Class 100,000 Cleanroom Assembly

HEPA-filtered, temperature- and humidity-controlled environment keeps every pen free from contamination during assembly.

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Dose Accuracy Verification

Batch sampling tests confirm dose delivery error stays below 5% per ISO 11608-1, plus injection force and dial function checks.

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Uncompromising Quality Control

100% visual inspection plus functional sampling of every batch before packing — appearance, clicks, display and button stroke.

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Global Compliance Support

Technical documentation for CE, FDA, KFDA and Anvisa registrations, handled by our in-house regulatory team.

Raw Material

Certified medical-grade ABS, PC and metal parts from ISO 9001 suppliers

Precision Molding

Injection molding of housing, dial and screw drive components

Clean Assembly

Automated mechanism assembly in Class 100,000 cleanroom

Function Testing

Dose accuracy, injection force, dial and display checks per batch

100% Inspection

Visual and functional check of every pen before packing

Sealed Packing

Individual color box with manual, batch number printed for traceability

PACKAGING & LOGISTICS

Protected Packing, On-Time Global Delivery

Each pen ships in an individual color box with instruction manual, then 100 boxes per reinforced export carton. Our export team arranges express, air or sea freight to 50+ countries — regular orders leave the factory within about 15 days.

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1 pc / Box

Individual retail-ready box with user manual and batch number printed.

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100 box / Carton

Reinforced export cartons protect pens and metal lids in long-distance transit.

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Express · Air · Sea

Flexible shipping methods matched to your order size, budget and timeline.

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~15-Day Lead Time

Regular orders ship in about 15 days; OEM timelines confirmed with your quote.

APPLICATIONS & WORKING PRINCIPLE

How the Pen Injector Works — and Where It Fits

A pen injector turns multi-dose cartridge therapy into a simple daily routine: load a 3ml cartridge, attach a pen needle, dial the dose and press the button. The mechanical screw drive pushes the cartridge stopper forward, delivering an exact volume through the needle.

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Accurate Dose, Every Time

Each dial click equals exactly 1IU (0.01ml). The high-precision screw drive moves the stopper in fixed steps, so the delivered dose matches the dialed dose with less than 5% error across the full 1–60IU range.

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Dial, Correct, Inject

The two-way dial lets users correct an over-dialed dose without wasting medication. Audible and tactile clicks confirm every step, and the display returns to zero automatically after a complete injection.

Insulin Pen Injector vs. Insulin Syringe

For brands and distributors choosing which format to carry, the difference is clear: pens simplify dosing, reduce errors and improve patient adherence — which is why pens now dominate insulin delivery in most developed markets.

Insulin Pen Injector

Featured & Preferred

Precise 1IU dial dosing — no manual drawing, fewer dosing errors

Large dose display with audible clicks — friendly to elderly and low-vision users

Fine, nearly hidden needle — less pain and less injection anxiety

Compact and discreet — easy multiple daily injections at work or while traveling

Better patient adherence, stronger brand loyalty and repeat cartridge sales

Insulin Syringe

(Traditional Option)

Manual dose drawing from a vial — higher risk of dosing errors

Requires steady hands and good eyesight to read the barrel scale

Fully visible needle — more fear and discomfort for patients

Vial plus syringe to carry — inconvenient for dosing away from home

Lower unit cost, mainly for price-driven or single-dose settings

One Platform, Multiple Therapies

Built around the standard 3ml cartridge, this pen serves diabetes care first — and the same platform adapts to GLP-1 weight-management drugs, growth hormone and other multi-dose injectables. For distributors, one device platform covers several fast-growing therapy markets.

Application	Typical Medication	Target Buyers
Diabetes Management	Insulin glargine, aspart, NPH and mixed insulins in 3ml cartridges	Diabetes care brands, pharmacies, clinics
Weight Management	GLP-1 analogues (custom mg scale available via OEM)	Pharma companies, wellness brands
Hormone Therapy	Growth hormone and other 3ml cartridge injectables	Distributors, hospitals, specialty clinics

USAGE & STORAGE

Simple Operation in Four Steps

Designed for patient self-injection and clinical use. Always follow the medication instructions and local regulations.

Load & Attach

Insert the 3ml cartridge into the holder and screw on a new sterile pen needle. Never reuse needles.

Prime the Pen

Dial 2IU and press the button with the needle pointing up until a drop appears at the needle tip.

Dial & Inject

Dial the prescribed dose, insert the needle subcutaneously, press the button fully and hold for 10 seconds.

Remove & Store

Remove and safely discard the needle, recap the pen with its metal lid, and store it properly.

Important Safety & Storage Guidelines

Always use a new sterile pen needle for every injection.
Never share the pen between patients, even with a new needle.
Do not store the pen with a needle attached — remove it after each use.
Store the pen at room temperature, away from direct sunlight and moisture.
Follow the medication leaflet for cartridge storage (typically 2–8°C before first use).
Keep out of reach of children. Wipe the pen body with a damp cloth only — never immerse in liquid.

OEM / ODM SERVICES

Launch Your Own Branded Pen Injector

As a direct manufacturer, we customize nearly every visible and functional detail of the pen. Send us your brand assets and target therapy — our team handles design, sampling, production and compliance documents. Custom orders start from 1,000 pcs, with delivery in about 15 days after design confirmation.

Body & Cap Colors

Custom colors for housing, dial and metal lid

Brand Logo

Silk-screen or laser logo printing on pen and box

Dose Scale

IU, mg or ml scales; custom dose ranges (60IU, 80IU, GLP-1)

Custom Packaging

Branded color boxes, manuals and export cartons

Cartridge Fit

Compatibility check for your specific 3ml cartridge

Compliance Files

Technical documentation support for your market registration

Send Requirements

Tell us dose range, colors, logo and packaging ideas

Design & Quote

We reply within 24 hours with pricing and design draft

Sample Approval

Physical samples made for your confirmation

Mass Production

Cleanroom production with full QC and batch records

Global Delivery

On-time shipping to 50+ countries with export support

Our Certifications

R&G Bio is an integrated manufacturer with verified FDA registration, ISO 13485 / ISO 9001 certification and EU RoHS compliance — the documentation your market actually requires.

U.S. FDA RegisteredEstablishment No. 3009392898 CE — RoHS VerifiedEU 2011/65/EU Compliant ISO 13485:2016Medical Device QMS Sterile · EO GasSingle-use, batch traceable

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Verified quality system — ISO 13485 / ISO 9001 certified factory, fully batch-traceable

Global market access — U.S. FDA registered, EU RoHS verified documentation

Custom certification support — if your market requires additional qualifications, we can assist in obtaining the relevant certifications. Contact us to discuss your requirements

FAQ

Frequently Asked Questions

Quick answers for wholesalers, brand owners and clinic buyers.