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MAGICL Progesterone (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref /Ref CLIA3022A
Identity
- Trade Name
- MAGICL Progesterone (CLIA) EUDAMED
- Device Name
- MAGICL Progesterone (CLIA) EUDAMED
- Model / Reference
- / EUDAMEDCLIA3022A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414798197 EUDAMED06954414750768 EUDAMED06954414750744 EUDAMED06954414750737 EUDAMED06954414750751 EUDAMED06954414750713 EUDAMED
- Basic UDI-DI
- B-06954414798197 EUDAMED695441479819L8 EUDAMED
- EMDN Code
- W0102050106 PROGESTERONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Netherlands 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 Progesterone (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-06954414798197 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06954414798197 | 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 (6)
- EUDAMED 4b064c23-bdf7-437e-a019-5a35965a9de3 61 fields · synced Aug 4, 2026
- EUDAMED b1e9b0b5-c20d-495a-8197-5d5682e8544d 61 fields · synced Jul 10, 2026
- EUDAMED 81de51a3-fa0f-49c6-918c-188fcaf13b4c 61 fields · synced Jul 11, 2026
- EUDAMED e3bd7c91-5774-4bbc-9836-2225ca4ae5f5 61 fields · synced Jul 11, 2026
- EUDAMED a59e7f0f-298f-4588-863d-172896993b59 61 fields · synced Jul 23, 2026
- EUDAMED 4919863f-2859-4b59-948b-cd8b02d9ea5b 61 fields · synced Aug 4, 2026