Identity
- Trade Name
- ACCU-FINE EUDAMED
- Device Name
- Pen needle EUDAMED
- Model / Reference
- type 810 EUDAMED8848 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999600358 EUDAMED
- Basic UDI-DI
- B-05903999600358 EUDAMED590799609810MR EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Norway 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
Accu-Fine by Htl Strefa S A — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05903999600358 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05903999600358 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (2)
- EUDAMED 7d49d92b-a32a-4978-83ef-b558248d8283 61 fields · synced Jun 18, 2026
- EUDAMED 5760bb97-648b-45f7-8345-f6f4d7b64539 61 fields · synced May 19, 2026