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GenePure 96 Nucleic Acid Purification System
EUDAMEDClass A (EU MDR)
Ref NPA-96 Model NPA-96, NPA-96T, NPA-96E
Identity
- Trade Name
- GenePure 96 Nucleic Acid Purification System EUDAMED
- Device Name
- GenePure 96 Nucleic Acid Purification System EUDAMED
- Model / Reference
- NPA-96, NPA-96T, NPA-96E EUDAMEDNPA-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843220598 EUDAMED
- Basic UDI-DI
- 697384322NPA003K4 EUDAMED
- Direct Marketing DI
- 06973843220598 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 96 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 | 697384322NPA003K4 | 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 e653b77a-3391-4570-a40a-650eddd496d3 61 fields · synced Jun 19, 2026