Identity
- Trade Name
- Nucleic Acid Extraction Kit EUDAMED
- Device Name
- Nucleic Acid Extraction Kit EUDAMED
- Model / Reference
- BH002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974901972602 EUDAMED
- Basic UDI-DI
- 6974901BH002TY EUDAMED
- EMDN Code
- W0105900101 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
Nucleic Acid Extraction Kit by Shandong Bohong Gene Technology 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 | 6974901BH002TY | Class A | Active |
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Manufacturer
- Manufacturer
- Shandong Bohong Gene Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025971
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 942e0d5c-37cf-4fff-a4b2-3c02c0bbdfe3 61 fields · synced Jun 19, 2026