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Automatic Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref HGMQ60 proBModel MQ60 proBRef HGMQ60 Model Please see IFU
Identity
- Trade Name
- Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- MQ60 proB EUDAMEDHGMQ60 proB EUDAMEDPlease see IFU EUDAMEDHGMQ60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936700403503 EUDAMED06936700403466 EUDAMED
- Basic UDI-DI
- 697029753MRBU3 EUDAMED697029753HG2J EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Automatic Chemiluminescence Immunoassay Analyzer by Beijing Hotgen Biotech 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 | 697029753MRBU3 | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing Hotgen Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000015566
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED a6f03c5c-46eb-488b-ada4-ee739b8395a5 61 fields · synced Jul 9, 2026
- EUDAMED 035d042f-e361-4506-a6fd-cc525a272306 61 fields · synced May 18, 2026