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Automated Workstation for Sample Preparation (Autra9600 Super)
EUDAMEDClass A (EU MDR)
Ref ZJYY-D-20229EModel Autra9600 Super
Identity
- Trade Name
- Automated Workstation for Sample Preparation (Autra9600 Super) EUDAMED
- Device Name
- Automated Workstation for Sample Preparation (Autra9600 Super) EUDAMED
- Model / Reference
- Autra9600 Super EUDAMEDZJYY-D-20229E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974613763123 EUDAMED
- Basic UDI-DI
- 697461376010008TB EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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 Workstation for Sample Preparation (Autra9600 Super) by Shanghai Zj Bio-Tech 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 | 697461376010008TB | Class A | Active |
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Manufacturer
- Manufacturer
- Shanghai ZJ Bio-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000023075
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED c0871fbc-cf4d-4145-b69d-698124f2b667 61 fields · synced Jun 18, 2026