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Tuning solution for the derivatized internal standard
EUDAMEDClass A (EU MDR)
Ref KM1002TS
Identity
- Trade Name
- Tuning solution for the derivatized internal standard EUDAMED
- Device Name
- Accessories for 1,25-(OH)2-Vitamin D3/D2 LC-MS/MS product variants EUDAMED
- Model / Reference
- KM1002TS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598012035 EUDAMED
- Basic UDI-DI
- 4050598LCACVITQV EUDAMED
- Direct Marketing DI
- 04050598012035 EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Yes
EUDAMED
Tuning solution for the derivatized internal standard by Immundiagnostik AG — Class A — 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 | 4050598LCACVITQV | Class A | Active |
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Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED 429a3108-9113-432b-8b7b-eaf3346d2dc2 61 fields · synced Jun 18, 2026