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3DMed BRCA1 and BRCA2 Gene Mutation Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref 3000000000382Model 12Tests/kit
Identity
- Device Name
- 3DMed BRCA1 and BRCA2 Gene Mutation Detection Kit EUDAMED
- Model / Reference
- 12Tests/kit EUDAMED3000000000382 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973685471271 EUDAMED
- Basic UDI-DI
- B-06973685471271 EUDAMED
- EMDN Code
- W01060203 BRCA 1+2 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
3DMed BRCA1 and BRCA2 Gene Mutation Detection Kit by 3D Biomedicine Science & Technology Co., Limited — 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-06973685471271 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- 3D Biomedicine Science & Technology Co., Limited
- EUDAMED SRN
- CN-MF-000020934
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED c47b663d-f735-4aab-a29b-43c487dc26e6 61 fields · synced Oct 7, 2026