Identity
- Trade Name
- Thermal Cycler EUDAMED
- Device Name
- PCR Thermal Cycler EUDAMEDThermal Cycler EUDAMED
- Model / Reference
- BH005 EUDAMEDTEC03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974901971391 EUDAMED06974901972404 EUDAMED
- Basic UDI-DI
- 6974901BH005U6 EUDAMED
- EMDN Code
- W02039006 DNA THERMAL CYCLERS 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
PCR Thermal Cycler 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 | 6974901BH005U6 | 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 (3)
- EUDAMED fa8ac47e-c8fc-46d0-94e1-1c90dbbda574 61 fields · synced Jul 25, 2026
- EUDAMED 1b9f71e2-0967-435c-94ae-19c006ded02f 61 fields · synced Jul 14, 2026
- EUDAMED 9ea73ca1-f3ab-4ce9-9d7a-1eb5cd23712b 61 fields · synced Jul 25, 2026