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GeneExplorer Thermal Cycler
EUDAMEDClass A (EU MDR)
Ref GE-DX/GE-96DS-AModel GE-96G, GE-96S, GE-48DG, GE-384G, GE-4I, GE-48D, GE-48DS,GE-DX
Identity
- Trade Name
- GeneExplorer Thermal Cycler EUDAMED
- Device Name
- GeneExplorer Thermal Cycler EUDAMED
- Model / Reference
- GE-96G, GE-96S, GE-48DG, GE-384G, GE-4I, GE-48D, GE-48DS,GE-DX EUDAMEDGE-DX/GE-96DS-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843221397 EUDAMED
- Basic UDI-DI
- 697384322TC001H3 EUDAMED
- Direct Marketing DI
- 06973843221397 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
GeneExplorer Thermal Cycler by Hangzhou Bioer 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 | 697384322TC001H3 | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019512
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED b901ea18-de98-4b4f-9c71-cbade5fb56fd 61 fields · synced May 22, 2026