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APTT Reagent (SP-UNICELIN)
EUDAMEDClass IVD General (EU MDR)
Ref 626 001Ref 626 002
Identity
- Trade Name
- APTT Reagent (SP-UNICELIN) EUDAMED
- Device Name
- APTT Reagent (SP-UNICELIN) EUDAMED
- Model / Reference
- 626 001 EUDAMED626 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041006666 EUDAMED62230041006734 EUDAMED
- Basic UDI-DI
- B-62230041006666 EUDAMEDB-62230041006734 EUDAMED
- EMDN Code
- W0103020102 ACTIVATED PARTIAL THROMBOPLASTIN TIME EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Denmark 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
APTT Reagent (SP-UNICELIN) 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-62230041006666 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED daa05a12-32e1-4c3e-bec5-75f59406ce59 61 fields · synced Oct 6, 2026
- EUDAMED 9c92c32a-3d03-48a6-8c87-c2ca29c37020 61 fields · synced May 18, 2026