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Chemistry and Immunoassay Integrated System
EUDAMEDClass A (EU MDR)
Ref IM9501033Model SAC-12, IOM-01, IOM-02, RWC-01, DQI-01, ST-04, ST-05, i 6000, C 1000, ISE
Identity
- Trade Name
- Chemistry and Immunoassay Integrated System EUDAMED
- Device Name
- Chemistry and Immunoassay Integrated System (LABAS S 9000) EUDAMED
- Model / Reference
- SAC-12, IOM-01, IOM-02, RWC-01, DQI-01, ST-04, ST-05, i 6000, C 1000, ISE EUDAMEDIM9501033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972168358580 EUDAMED
- Basic UDI-DI
- 6972168356008B3 EUDAMED
- Direct Marketing DI
- 06972168358580 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER 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
Chemistry and Immunoassay Integrated System 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 | 6972168356008B3 | Class A | Active |
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Manufacturer
- Manufacturer
- Maccura Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000028087
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED 65aa9f47-ac25-49f8-b04d-e2b621188d5e 61 fields · synced Jun 19, 2026