← Back to catalogue
Automated Workstation for Nucleic Acid Extraction and PCR Test
EUDAMEDClass A (EU MDR)
Ref ZJYY-D-20215EModel AutraMicMini 3200Ref ZJYY-D-20216EModel AutraMic mini4800Ref ZJYY-D-20221EModel AutraMic mini4800 Plus
Identity
- Device Name
- Automated Workstation for Nucleic Acid Extraction and PCR Test EUDAMEDAutomated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini4800 Plus) EUDAMED
- Model / Reference
- AutraMicMini 3200 EUDAMEDZJYY-D-20215E EUDAMEDAutraMic mini4800 EUDAMEDZJYY-D-20216E EUDAMEDAutraMic mini4800 Plus EUDAMEDZJYY-D-20221E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974613762041 EUDAMED06974613762058 EUDAMED06974613760191 EUDAMED
- Basic UDI-DI
- 697461376020001T8 EUDAMED697461376020002TA EUDAMED697461376020003TC 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
Yes
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 Nucleic Acid Extraction and PCR Test 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 | 697461376020001T8 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai ZJ Bio-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000023075
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 266a5081-950b-4bb4-94a5-395a2a1b5de0 61 fields · synced Oct 6, 2026
- EUDAMED 49d51298-6f17-412d-aa4e-792135b78dc1 61 fields · synced May 19, 2026
- EUDAMED 9618773e-1c43-4023-a835-fffdb6ea5fb9 61 fields · synced May 19, 2026