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PROG STAT (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320510603Model 100 TRef 0320510601Model 50TRef 0320510602Model 2×50 T
Identity
- Trade Name
- PROG STAT (eCLIA) EUDAMED
- Device Name
- PROG STAT (eCLIA) EUDAMED
- Model / Reference
- 100 T EUDAMED0320510603 EUDAMED50T EUDAMED0320510601 EUDAMED2×50 T EUDAMED0320510602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984063799 EUDAMED06975984063775 EUDAMED06975984063782 EUDAMED
- Basic UDI-DI
- B-06975984063799 EUDAMEDB-06975984063775 EUDAMEDB-06975984063782 EUDAMED
- EMDN Code
- W0102050106 PROGESTERONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
PROG STAT (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975984063799 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED 715d36d9-5b39-406f-9ac6-969e55561231 61 fields · synced Jul 31, 2026
- EUDAMED cbd624e2-4fe4-4d99-b4f5-54c71ad86748 61 fields · synced May 18, 2026
- EUDAMED 50fb0601-58b4-4707-8f56-044c7558d5b6 61 fields · synced May 19, 2026