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Automated Nucleic Acid Extraction Workstation
EUDAMEDClass A (EU MDR)
Ref SAW-48Model SAW-96, SAW-48
Identity
- Trade Name
- Automated Nucleic Acid Extraction Workstation EUDAMED
- Device Name
- Automated Nucleic Acid Extraction Workstation EUDAMED
- Model / Reference
- SAW-96, SAW-48 EUDAMEDSAW-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973342003357 EUDAMED
- Basic UDI-DI
- 697334200SAW96GD EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER 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
Automated Nucleic Acid Extraction Workstation by Jiangsu Bioperfectus Technologies 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 | 697334200SAW96GD | Class A | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED c00d548b-e661-44b9-90a7-5653069117f1 61 fields · synced Jun 19, 2026