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Thyroid Function Control
EUDAMEDClass B (EU MDR)
Ref EIM4499051Model EIM4489051 EIM4488051 EIM4487051 EIM4486051 EIM4485051 EIM4484051 EIM4483051 EIM4482051 EIM4481051 EIM4499051 EIM4498051 EIM4497051 EIM4496051 EIM4495051 EIM4494051 EIM4493051 EIM4492051 EIM4491051
Identity
- Device Name
- Thyroid Function Control EUDAMED
- Model / Reference
- EIM4489051 EIM4488051 EIM4487051 EIM4486051 EIM4485051 EIM4484051 EIM4483051 EIM4482051 EIM4481051 EIM4499051 EIM4498051 EIM4497051 EIM4496051 EIM4495051 EIM4494051 EIM4493051 EIM4492051 EIM4491051 EUDAMEDEIM4499051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950617402404 EUDAMED
- Basic UDI-DI
- 69506174IM449051F4 EUDAMED
- Direct Marketing DI
- 06950617402404 EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Thyroid Function Control by Maccura Biotechnology Co., Ltd. — Class B — 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 | 69506174IM449051F4 | Class B | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 4d638393-5dca-4dee-a81d-96c27971edf2 61 fields · synced Oct 5, 2026