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GenePure Pro 9600 Nucleic Acid Purification System
EUDAMEDClass A (EU MDR)
Ref NPAm-9600
Identity
- Trade Name
- GenePure Pro 9600 Nucleic Acid Purification System EUDAMED
- Device Name
- GenePure Pro 9600 Nucleic Acid Purification System EUDAMED
- Model / Reference
- NPAm-9600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843221205 EUDAMED
- Basic UDI-DI
- 697384322NPA005K8 EUDAMED
- Direct Marketing DI
- 06973843221205 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
GenePure Pro 9600 Nucleic Acid Purification System 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 | 697384322NPA005K8 | 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 d25267c6-b227-45c4-a1ee-08603c98777c 61 fields · synced Jun 20, 2026