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D-Dimer Rapid Test Device (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref B011016DRef B010216D
Identity
- Trade Name
- D-Dimer Rapid Test Device (Colloidal Gold) EUDAMED
- Model / Reference
- B011016D EUDAMEDB010216D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971792053816 EUDAMED06971792054028 EUDAMED
- Basic UDI-DI
- B-06971792053816 EUDAMEDB-06971792054028 EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
D-Dimer Rapid Test Device (Colloidal Gold) by Hangzhou Realy Tech Co., Ltd. — 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-06971792053816 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Realy Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000004716
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 92474103-966c-4b9d-ae7e-d4840f3db71e 61 fields · synced Aug 3, 2026
- EUDAMED dbee3739-8075-4535-bf53-fe7ae3aea726 61 fields · synced May 19, 2026