Identity
- Trade Name
- Pregnenolone sulfate Calibrator Set EUDAMED
- Device Name
- Pregnenolone sulfate LC-MS/MS EUDAMED
- Model / Reference
- YM2000CAL1-6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598014145 EUDAMED
- Basic UDI-DI
- 4050598DVPhysiolW8 EUDAMED
- Direct Marketing DI
- 04050598014145 EUDAMED
- EMDN Code
- W0102152208 STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
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
New Device
Yes
EUDAMED
Pregnenolone sulfate Calibrator Set by Immundiagnostik AG — 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 | 4050598DVPhysiolW8 | Class B | Active |
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Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED 312a898b-dca8-4e5b-a2be-49cac07ab0d5 61 fields · synced Jul 17, 2026