Identity
- Device Name
- Bacterial DNA Extraction Kit EUDAMED
- Model / Reference
- B2010-50T EUDAMEDB2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323019251 EUDAMED06979502241508 EUDAMED
- Basic UDI-DI
- 697432301B2010YU EUDAMED697950224B20107U EUDAMED
- EMDN Code
- W05030399 MICROBIOLOGY DEVICES - OTHER EUDAMEDW0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A 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
New Device
No
EUDAMED
Bacterial DNA Extraction Kit by Beijing Applied Biological Technologies 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 | 697432301B2010YU | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 1737ac45-1c2f-482c-ac01-016a247c97a7 61 fields · synced Jul 18, 2026
- EUDAMED fef75d68-afa4-4784-935d-0c2993cd428e 61 fields · synced Jul 18, 2026