Identity
- Trade Name
- Nucleic Acid Purification System EUDAMED
- Device Name
- Nucleic Acid Purification System EUDAMED
- Model / Reference
- BGNA-32P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16980047303009 EUDAMED
- Basic UDI-DI
- 698004730300FQ EUDAMED
- Direct Marketing DI
- 16980047303009 EUDAMED
- EMDN Code
- W02050106 DNA GENOMIC PREPARATION DEVICES 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
Nucleic Acid Purification System by Hangzhou Bio-gener 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 | 698004730300FQ | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bio-gener Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027988
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 992d1c26-a860-4f3e-9782-d0798d4676e8 61 fields · synced Jul 20, 2026