Identity
- Trade Name
- MAGICL TSH (CLIA) EUDAMED
- Device Name
- MAGICL TSH (CLIA) EUDAMED
- Model / Reference
- 、 EUDAMEDCLIA3012A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414798104 EUDAMED06954414728910 EUDAMED06954414728279 EUDAMED
- Basic UDI-DI
- B-06954414798104 EUDAMED695441479810KN EUDAMED
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Romania EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
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
Magicl Tsh (clia) by Getein Biotech, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06954414798104 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06954414798104 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED d9bf5af9-67ed-48cc-81f2-98bf6abefb6f 61 fields · synced Jul 29, 2026
- EUDAMED 7efb0c62-4fe0-43a5-8f01-db7f2633388f 61 fields · synced Jul 18, 2026
- EUDAMED 122b20ca-15d5-40b3-8bf0-db14dac98152 61 fields · synced Jul 29, 2026