Identity
- Trade Name
- Nucleic Acid Extractor EUDAMED
- Device Name
- Nucleic Acid Extractor EUDAMED
- Model / Reference
- BH003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974901970035 EUDAMED06974901970028 EUDAMED06974901970059 EUDAMED06974901970011 EUDAMED
- Basic UDI-DI
- 6974901BH003U2 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
Nucleic Acid Extractor by Shandong Bohong Gene Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6974901BH003U2 | 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 (8)
- EUDAMED afa4d12d-4103-443e-ac98-02533dc9f5c4 61 fields · synced Aug 3, 2026
- EUDAMED b9704e75-b463-410c-8144-fe429077bb8f 61 fields · synced May 19, 2026
- EUDAMED 5bb3c3df-1748-4209-ae7a-d78aaaebd8c4 61 fields · synced May 19, 2026
- EUDAMED 0b37235d-4d48-44b6-9bed-c339aeba90f8 61 fields · synced May 19, 2026
- EUDAMED da189af2-fa8e-48c6-b7be-c27629cc8ddb 61 fields · synced Jul 11, 2026
- EUDAMED 80846e86-cd25-44db-9c26-a34a63971cac 61 fields · synced Jul 16, 2026
- EUDAMED d3a16edb-5f21-405f-a147-4a18f5f7d622 61 fields · synced Jul 17, 2026
- EUDAMED 234efb6b-4c7c-400b-bbe8-77b9cd0d15ee 61 fields · synced Aug 3, 2026