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Automated Nucleic Acid Extraction Instrument（EX1600）
EUDAMEDClass A (EU MDR)
Ref ZJYY-D-10075EModel EX1600
Identity
- Device Name
- Automated Nucleic Acid Extraction Instrument（EX1600） EUDAMED
- Model / Reference
- EX1600 EUDAMEDZJYY-D-10075E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974613762027 EUDAMED
- Basic UDI-DI
- 697461376010001SV EUDAMED
- EMDN Code
- W0299 IVD 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 Nucleic Acid Extraction Instrument（EX1600） 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 | 697461376010001SV | 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 e71544d6-71e7-4cb3-992a-f0491cdf8eef 61 fields · synced Sep 18, 2026