← Back to catalogue
Automatic Chemistry Analyzer
EUDAMEDClass A (EU MDR)
Ref CH9201105Model C 400, C410, C 600, C 610, C 1000, C 1100
Identity
- Trade Name
- Automatic Chemistry Analyzer EUDAMED
- Device Name
- Automatic Chemistry Analyzer EUDAMED
- Model / Reference
- C 400, C410, C 600, C 610, C 1000, C 1100 EUDAMEDCH9201105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168358009 EUDAMED
- Basic UDI-DI
- 69721683510059S EUDAMED
- Direct Marketing DI
- 06972168358009 EUDAMED
- EMDN Code
- W0201010103 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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 Chemistry Analyzer by Maccura Medical Instrument 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 | 69721683510059S | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maccura Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028087
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (2)
- EUDAMED 69a5edd7-3657-4b6e-a614-5bff8f425533 61 fields · synced Jun 19, 2026
- EUDAMED ff745e0e-63f4-4fb6-af4c-205b2cab562c 61 fields · synced Jun 19, 2026