← Back to catalogue
Automatic Nucleic Acid Purification Instrument
EUDAMEDClass A (EU MDR)
Ref E-96
Identity
- Trade Name
- Automatic Nucleic Acid Purification Instrument EUDAMED
- Device Name
- Automatic Nucleic Acid Purification Instrument EUDAMED
- Model / Reference
- E-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974677691158 EUDAMED
- Basic UDI-DI
- 6974677691158JN EUDAMED
- Direct Marketing DI
- 06974677691158 EUDAMED
- EMDN Code
- W02060201 POST-ANALYSIS SAMPLE ARCHIVING SYSTEMS - INSTRUMENTS 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic Nucleic Acid Purification Instrument by Shanghai BioGerm Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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 | 6974677691158JN | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai BioGerm Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018164
- Authorised Representative
- PureCE B.V. NL-AR-000006069
Sources (1)
- EUDAMED 21dcba68-8dae-4d94-98ec-a2ab1a90a57c 61 fields · synced Jul 17, 2026