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Progesterone Controls
EUDAMEDClass IVD General (EU MDR)
Ref 1030292000Model Prog Control 1: 2 × 2 mL, Prog Control 2: 2 × 2 mLRef 1030291000Model Prog Control 1: 1 × 2 mL, Prog Control 2: 1 × 2 mL
Identity
- Device Name
- Progesterone Controls EUDAMED
- Model / Reference
- Prog Control 1: 2 × 2 mL, Prog Control 2: 2 × 2 mL EUDAMED1030292000 EUDAMEDProg Control 1: 1 × 2 mL, Prog Control 2: 1 × 2 mL EUDAMED1030291000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975090501338 EUDAMED06975090500331 EUDAMED
- Basic UDI-DI
- B-06975090501338 EUDAMEDB-06975090500331 EUDAMED
- EMDN Code
- W0102152002 HORMONE CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Progesterone Controls by Accucise Diagnostics Inc. — 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-06975090501338 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Accucise Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000045017
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED a86fa2d0-3326-4384-b59c-a57eeba571fd 61 fields · synced Jul 8, 2026
- EUDAMED 2a7248ef-a7d1-401c-848b-debd24a429ea 61 fields · synced May 17, 2026