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Accu-Fine
EUDAMEDClass IIa (EU MDR)
Ref 8800Model Type 810Ref 8801Ref 8825Ref 8851Ref 7895Ref 8849Ref 8824Ref 7896Ref 8850
Identity
- Trade Name
- Accu-Fine EUDAMED
- Device Name
- Pen needle EUDAMED
- Model / Reference
- Type 810 EUDAMED8800 EUDAMED8801 EUDAMED8825 EUDAMED8851 EUDAMED7895 EUDAMED8849 EUDAMED8824 EUDAMED7896 EUDAMED8850 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996098590 EUDAMED05907996098606 EUDAMED05907996099238 EUDAMED05903999600389 EUDAMED05903999603779 EUDAMED05903999600365 EUDAMED05907996099139 EUDAMED05903999603786 EUDAMED05903999600372 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
- Slovenia EUDAMEDSpain EUDAMEDItaly EUDAMEDPortugal EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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 — 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 (9)
- EUDAMED 9676a5f0-eb5e-4c69-a63b-be2e1dfe239b 61 fields · synced Jul 29, 2026
- EUDAMED 29c9febf-533a-4437-b5c5-9aff366e988c 61 fields · synced May 16, 2026
- EUDAMED 718c9e30-b6f3-4395-81ae-ec42d62f04ca 61 fields · synced May 16, 2026
- EUDAMED c81ec5c8-d86e-4a27-82e3-c96b4740ef8c 61 fields · synced May 17, 2026
- EUDAMED 6781f50b-ad84-498f-b69d-622875704be9 61 fields · synced May 17, 2026
- EUDAMED d93bd4ba-1939-4bec-ba4e-4466da84d372 61 fields · synced May 18, 2026
- EUDAMED 3ae3114c-f3dc-47a7-a612-a456fa6c168d 61 fields · synced May 18, 2026
- EUDAMED 55edfab8-fc18-4e49-930f-143ec1b64427 61 fields · synced May 18, 2026
- EUDAMED 0d1870f7-06d6-4ee4-a691-918d07467646 61 fields · synced May 19, 2026