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Progesterone（CLIA）
EUDAMEDClass B (EU MDR)
Ref 105-004228-00Model 105-004228-00、105-004255-00、105-004295-00
Identity
- Trade Name
- Progesterone（CLIA） EUDAMED
- Device Name
- Progesterone（CLIA）、Progesterone Calibrators EUDAMED
- Model / Reference
- 105-004228-00、105-004255-00、105-004295-00 EUDAMED105-004228-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904047829 EUDAMED
- Basic UDI-DI
- 69449040AB74000055E EUDAMED
- EMDN Code
- W0102050106 PROGESTERONE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
Progesterone（CLIA） by Shenzhen Mindray Bio-Medical Electronics 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 | 69449040AB74000055E | Class B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1f3d9b8b-6730-49eb-930f-3a3b45d19e43 61 fields · synced Jun 18, 2026