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Pefakit® APC-R Factor V Leiden Controls
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref 502-21
Identity
- Trade Name
- Pefakit® APC-R Factor V Leiden Controls EUDAMED
- Device Name
- Pefakit® APC-R Factor V Leiden Controls EUDAMED
- Model / Reference
- 502-21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640175460051 EUDAMED
- Basic UDI-DI
- B-07640175460051 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
No
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 Factor V Leiden Controls by Pentapharm AG — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042762 | Class IVD General | Active |
| FDA 510(k) | United States | FDA_510K | K042760 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-07640175460051 | 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 (2)
- EUDAMED eb534b9c-73c7-4990-9811-3da5674fce84 61 fields · synced Jun 19, 2026
- FDA 510(k) K042762 1 fields · synced May 18, 2026