Identity
- Trade Name
- Pefakit® Reptilase® Time EUDAMED
- Device Name
- Pefakit® Reptilase® Time EUDAMED
- Model / Reference
- 800191 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640175460082 EUDAMED
- Basic UDI-DI
- B-07640175460082 EUDAMED
- EMDN Code
- W0103020103 THROMBIN TIME / REPTILASE / BATROXOBIN TIME EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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® Reptilase® Time 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-07640175460082 | 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 d2c41d09-ff28-4c4a-8e3e-4aed46d47b93 61 fields · synced Jul 26, 2026