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Recoplastin ISI 1.0 PT Reagent
EUDAMEDClass IVD General (EU MDR)
Ref 624 003Ref 624 001Ref 624 002
Identity
- Trade Name
- Recoplastin ISI 1.0 PT Reagent EUDAMED
- Device Name
- Recoplastin ISI 1.0 PT Reagent EUDAMED
- Model / Reference
- 624 003 EUDAMED624 001 EUDAMED624 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041031934 EUDAMED62230041031798 EUDAMED62230041031866 EUDAMED
- Basic UDI-DI
- B-62230041031934 EUDAMEDB-62230041031798 EUDAMEDB-62230041031866 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
Recoplastin ISI 1.0 PT Reagent 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-62230041031934 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 66f835a7-1201-4517-9e64-b23c9728004d 61 fields · synced Oct 6, 2026
- EUDAMED fb19e868-d4ef-42bd-94ea-e4571529777a 61 fields · synced May 18, 2026
- EUDAMED ddbf52c1-85f3-4fcd-b307-8f2e330645ba 61 fields · synced May 18, 2026