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TIANamp Blood DNA Kit
EUDAMEDClass A (EU MDR)
Ref CDP348-02Model CDP348-02, CDP348-03Ref CDP348-03
Identity
- Trade Name
- TIANamp Blood DNA Kit EUDAMED
- Device Name
- TIANamp Blood DNA Kit EUDAMED
- Model / Reference
- CDP348-02, CDP348-03 EUDAMEDCDP348-02 EUDAMEDCDP348-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489971087 EUDAMED06975489971094 EUDAMED
- Basic UDI-DI
- 697548997CDP348U5 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
New Device
No
EUDAMED
TIANamp Blood DNA Kit by Tiangen Biotech (Beijing) Co., Ltd. — Class A — 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 | 697548997CDP348U5 | Class A | Active |
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Manufacturer
- Manufacturer
- Tiangen Biotech (Beijing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000026594
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (2)
- EUDAMED 0185a8d3-3a6a-4c48-a3ef-0b36651ea4e9 61 fields · synced Jul 30, 2026
- EUDAMED 29999119-813f-4974-ba43-69b331458a43 61 fields · synced May 17, 2026