← Back to catalogue
PT Reagent (SP-Normoplastin)
EUDAMEDClass IVD General (EU MDR)
Ref 614 001Ref 614 002
Identity
- Trade Name
- PT Reagent (SP-Normoplastin) EUDAMED
- Device Name
- PT Reagent (SP-Normoplastin) EUDAMED
- Model / Reference
- 614 001 EUDAMED614 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041031002 EUDAMED62230041031170 EUDAMED
- Basic UDI-DI
- B-62230041031002 EUDAMEDB-62230041031170 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
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
PT Reagent (SP-Normoplastin) by Egyptian Company For Biotechnology-Spectrum Diagnostics — 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-62230041031002 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 67912e3a-7838-4f87-ac68-e161393ab3d1 61 fields · synced Jul 9, 2026
- EUDAMED b96c78b7-b4a8-4a99-95b4-3b3f4e77ce8e 61 fields · synced May 19, 2026