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D-Dimer Turbi Latex
EUDAMEDClass IVD General (EU MDR)
Ref 585 002-1Ref 585 002Ref 585 004Ref 585 003
Identity
- Trade Name
- D-Dimer Turbi Latex EUDAMED
- Device Name
- D-Dimer Turbi Latex EUDAMED
- Model / Reference
- 585 002-1 EUDAMED585 002 EUDAMED585 004 EUDAMED585 003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041019772 EUDAMED62230041019604 EUDAMED62230041019918 EUDAMED62230041019840 EUDAMED
- Basic UDI-DI
- B-62230041019772 EUDAMEDB-62230041019604 EUDAMEDB-62230041019918 EUDAMEDB-62230041019840 EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
D-Dimer Turbi Latex by Egyptian Company For Biotechnology-Spectrum Diagnostics — 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-62230041019772 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED 42ea4f72-ae32-4fec-8b4f-18e367e5f9e5 61 fields · synced Oct 6, 2026
- EUDAMED 3df25d1a-e604-400d-846a-565d3656c3bc 61 fields · synced May 17, 2026
- EUDAMED abf3b010-1796-4db9-9653-bd741ca37279 61 fields · synced May 17, 2026
- EUDAMED 4e3b5e99-6d73-4234-a454-faf7edf17589 61 fields · synced May 18, 2026