Identity
- Trade Name
- Pefakit® APC-R Faktor V Leiden EUDAMED
- Device Name
- Pefakit® APC-R Factor V Leiden EUDAMED
- Model / Reference
- 502-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640175460044 EUDAMED
- Basic UDI-DI
- B-07640175460044 EUDAMED
- EMDN Code
- W0103020610 APC RESISTANCE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Pefakit® APC-R Faktor V Leiden by Pentapharm AG — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-07640175460044 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Pentapharm AG
- EUDAMED SRN
- CH-MF-000020620
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 3946ed8c-f6b7-4b84-829b-baf08dcbb5a2 61 fields · synced Jun 18, 2026