Identity
- Trade Name
- AviFine EUDAMED
- Device Name
- Pen needle EUDAMED
- Model / Reference
- Type 810 EUDAMED7726 EUDAMED7728 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999602482 EUDAMED05903999602505 EUDAMED
- Basic UDI-DI
- 590799609810MR EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AviFine by Htl Strefa S A — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 590799609810MR | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (2)
- EUDAMED 55565ac4-89eb-4c02-9c4b-610a6df1abb8 61 fields · synced Jul 30, 2026
- EUDAMED e6eef2c8-b88d-4964-abb7-0def3a011d94 61 fields · synced May 18, 2026