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Clickfine
EUDAMEDClass IIa (EU MDR)
Ref 7791Model Type 810.04Ref 7797Ref 7806Ref 7794Ref 7795
Identity
- Trade Name
- Clickfine EUDAMED
- Device Name
- Pen needle EUDAMED
- Model / Reference
- Type 810.04 EUDAMED7791 EUDAMED7797 EUDAMED7806 EUDAMED7794 EUDAMED7795 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903999607999 EUDAMED05903999608477 EUDAMED05903999608620 EUDAMED05903999608293 EUDAMED05903999608309 EUDAMED
- Basic UDI-DI
- 590799609810046R EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMEDFrance EUDAMEDBelgium EUDAMEDGermany 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
Clickfine 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 | 590799609810046R | Class IIa | Active |
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Manufacturer
- Manufacturer
- HTL-Strefa S.A.
- EUDAMED SRN
- PL-MF-000002198
Sources (5)
- EUDAMED e2e9f58b-191b-403e-ae35-e6a523c0a77d 61 fields · synced Jul 24, 2026
- EUDAMED c315b741-959b-4c32-8fff-58efecf25226 61 fields · synced May 18, 2026
- EUDAMED b67ad633-94be-41e8-a169-f284bf80b767 61 fields · synced Jul 13, 2026
- EUDAMED 5ea407a4-fd80-4534-84a7-f7d4e9994904 61 fields · synced Jul 13, 2026
- EUDAMED 1b9d6a14-a965-420b-a7e4-882e7442e10b 61 fields · synced Jul 21, 2026