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Prothrombin Time (PT) Test Kit (Coagulation)
EUDAMEDClass IVD General (EU MDR)
Ref Quality control plasma (normal): 1.0mL×1（521011）
Identity
- Trade Name
- Prothrombin Time (PT) Test Kit (Coagulation) EUDAMED
- Device Name
- Prothrombin Time (PT) Test Kit (Coagulation) EUDAMED
- Model / Reference
- Quality control plasma (normal): 1.0mL×1（521011） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936895303695 EUDAMED
- Basic UDI-DI
- B-06936895303695 EUDAMED
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Prothrombin Time (PT) Test Kit (Coagulation) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06936895303695 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 898ff06f-acc3-4591-8e3b-2c19cd7c49c5 61 fields · synced Sep 17, 2026