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Chemiluminescent Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref HE10016Model MI200
Identity
- Device Name
- Chemiluminescent Immunoassay Analyzer EUDAMED
- Model / Reference
- MI200 EUDAMEDHE10016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975838807555 EUDAMED
- Basic UDI-DI
- 697583880MI003NN EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Chemiluminescent Immunoassay Analyzer by Zhejiang Pushkang Biotechnology 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 | 697583880MI003NN | Class A | Active |
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Manufacturer
- Manufacturer
- Zhejiang Pushkang Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000042656
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 24f3827d-2691-48bd-8b33-7e9d8c6a4acc 61 fields · synced Jun 18, 2026