Identity
- Trade Name
- D-Dimer Assay Kit EUDAMED
- Device Name
- D-Dimer Assay Kit(D-D) (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- ETGS8601M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936736067700 EUDAMED
- Basic UDI-DI
- 697030147BSBE0001H9 EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
D-Dimer Assay Kit by Beijing Strong Biotechnologies, Inc. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697030147BSBE0001H9 | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Strong Biotechnologies, Inc.
- EUDAMED SRN
- CN-MF-000004362
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c9a3c250-d4e6-444a-b592-bb119b32b403 61 fields · synced Jul 21, 2026