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WellFine®
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 32G(0.23mm) x 6mmModel WellFine® 32G(0.23mm) x 6mm
Identity
- Trade Name
- WellFine® EUDAMEDFDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Insulin Pen Needle EUDAMEDWell Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm, and 12.7mm). Well Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Well Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper. FDA UDI
- Model / Reference
- WellFine® 32G(0.23mm) x 6mm EUDAMED32G(0.23mm) x 6mm EUDAMEDWellFine®Insulin Pen Needles 31Gx8mm 100pcs FDA UDI
- Description
- Well Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm, and 12.7mm). Well Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Well Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809445830737 EUDAMED08809445831949 FDA UDI
- Basic UDI-DI
- B-08809445830737 EUDAMED
- 510(k) Number
- K152410 FDA UDI
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Millimeter FDA UDINeedle Gauge — 31 Gauge FDA UDI
Category: Hypodermic needle, single-use
WellFine® by Medexel Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hypodermic needle, single-use.
- Monoject — Cardinalhealth · Class II
- Pinpoint GT — Bard Access Systems, Inc. · Class II
- Safety Needle — Jiangsu Micsafe Medical Technology Co., Ltd · Class IIa
- Syringe w/Needle, Non-Toxic, 25G x 1", Luer Lock — Dynarex Corp. · Class II
- Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
- EasyTouch — MHC Medical Products · Class II
- STERiJECT TM — TSK LABORATORY, JAPAN · Class II
- Comfort EZ Pro — S.D.I. USA, INC. · Class II
Cleared under the same submission
K152410 also covers:
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- Good Neighbor Pharmacy — Amerisourcebergen Drug Corporation
- TopFine® — MEDEXEL CO., LTD.
- TopFine® — MEDEXEL CO., LTD.
- TopFine® — MEDEXEL CO., LTD.
- TopFine® — MEDEXEL CO., LTD.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medexel Co., Ltd.
Sources (2)
- FDA UDI 7d170e39-6b21-4dda-bd5f-e577d97391b4 36 fields · synced Aug 1, 2026
- EUDAMED 6a2d2604-7009-4cce-bdd0-8cc9411fbdac 61 fields · synced Aug 1, 2026