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Tuning solution for the internal standard
EUDAMEDClass A (EU MDR)
Ref KM1000TSRef KM2000TS
Identity
- Trade Name
- Tuning solution for the internal standard EUDAMED
- Device Name
- Accessories for 1,25-(OH)2-Vitamin D3/D2 LC-MS/MS product variants EUDAMEDAccessories for Pregnolone sulfate LC-MS/MS EUDAMED
- Model / Reference
- KM1000TS EUDAMEDKM2000TS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598012004 EUDAMED04050598013827 EUDAMED
- Basic UDI-DI
- 4050598LCACVITQV EUDAMED4050598LCACPhysiolLL EUDAMED
- Direct Marketing DI
- 04050598012004 EUDAMED04050598013827 EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMEDW0102152208 STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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
EUDAMEDEUDAMED
Tuning solution for the 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 (2)
- EUDAMED a515964b-8b40-418f-b2f3-a6fa47c266a7 61 fields · synced Jul 13, 2026
- EUDAMED 018b3b9b-b27b-4dea-9c9d-72cba067a764 61 fields · synced May 17, 2026