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Automated Nucleic Acid Extraction Instrument (EX1600 Plus)
EUDAMEDClass A (EU MDR)
Ref ZJYY-D-20231EModel EX1600 Plus
Identity
- Device Name
- Automated Nucleic Acid Extraction Instrument (EX1600 Plus) EUDAMED
- Model / Reference
- EX1600 Plus EUDAMEDZJYY-D-20231E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974613763130 EUDAMED
- Basic UDI-DI
- 697461376010009TD 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 Nucleic Acid Extraction Instrument (EX1600 Plus) by Shanghai Zj Bio-Tech 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 | 697461376010009TD | 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 d4f519c9-dfe0-4a10-b946-c2697eea0300 61 fields · synced Jul 13, 2026