GenePure Pro 16H Nucleic Acid Purification System
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- GenePure Pro 16H Nucleic Acid Purification System EUDAMEDFDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- GenePure Pro 16H Nucleic Acid Purification System EUDAMEDFor the detail information, please refer to the IFU. FDA UDI
- Model / Reference
- NPA-16H EUDAMEDFDA UDI
- Description
- For the detail information, please refer to the IFU. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973843221274 EUDAMED06973843220864 FDA UDI
- Basic UDI-DI
- 697384322NPA001JY EUDAMED
- Direct Marketing DI
- 06973843221274 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Nucleic acid sample preparation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 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
GenePure Pro 16H Nucleic Acid Purification System by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 697384322NPA001JY | 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 a72e9976-7f9a-421b-bf30-23cfc2d8fd11 61 fields · synced Jul 15, 2026
- FDA UDI c1c14ab8-ae54-40c3-a4b8-1ec4d3134f6c 33 fields · synced May 29, 2026