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TopFine®
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 32Gx4mm(G)Model 192 models including '29Gx8mm(R)'
Identity
- Trade Name
- TopFine® EUDAMEDFDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Insullin Pen Needle EUDAMEDTop 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). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Top Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper. FDA UDI
- Model / Reference
- 192 models including '29Gx8mm(R)' EUDAMED32Gx4mm(G) EUDAMEDTopFine®Insulin Pen Needles 32Gx4mm 100pcs FDA UDI
- Description
- Top 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). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic. Top Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809445832090 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809445832090 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
- Needle Gauge — 32 Gauge FDA UDILength — 4 Millimeter FDA UDI
TopFine® by Medexel Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809445832090 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medexel Co., Ltd.
- EUDAMED SRN
- KR-MF-000016654
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED b70c5325-f9e0-43ac-a924-dccfd4e16587 61 fields · synced Jul 11, 2026
- FDA UDI a8594821-4a8c-4798-a6b2-9c7738d2bbf1 37 fields · synced May 29, 2026