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3DMed BRCA1 and BRCA2 Gene Mutation Detection Kit (Reversible Terminator Sequen…
EUDAMEDClass IVD General (EU MDR)
Ref 3000000000379Model 12 tests
Identity
- Device Name
- 3DMed BRCA1 and BRCA2 Gene Mutation Detection Kit (Reversible Terminator Sequencing EUDAMED
- Model / Reference
- 12 tests EUDAMED3000000000379 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973685471240 EUDAMED
- Basic UDI-DI
- B-06973685471240 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 (Reversible Terminator Sequen… by 3D Biomedicine Science & Technology Co., Limited — Class IVD General…
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-06973685471240 | 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 d4832377-6010-41d9-ac48-fc0ed73ef52f 61 fields · synced Oct 8, 2026