GeneExplorer Thermal Cycler
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- GeneExplorer Thermal Cycler EUDAMEDBIOER GeneExplorer Thermal Cycler FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- GeneExplorer Thermal Cycler EUDAMEDFor the detail information, please refer to the IFU. FDA UDI
- Model / Reference
- GE-96G, GE-96S, GE-48DG, GE-384G, GE-4I, GE-48D, GE-48DS,GE-DX EUDAMEDGE-96G EUDAMEDFDA UDI
- Description
- For the detail information, please refer to the IFU. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973843220734 EUDAMED06973843220277 FDA UDI
- Basic UDI-DI
- 697384322TC001H3 EUDAMED
- Direct Marketing DI
- 06973843220734 EUDAMED
- FDA Product Code
- OOI FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Nucleic acid sample preparation instrument IVD
GeneExplorer Thermal Cycler by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697384322TC001H3 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 (2)
- EUDAMED f99d6d68-97da-4d91-8b5a-d328c3d55eb1 61 fields · synced Jun 6, 2026
- FDA UDI 724b2b7c-ec77-4ab1-8c33-0e9dab173947 33 fields · synced May 30, 2026