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IDK® Bile Acids (cuvette version +1 more model
EUDAMEDClass IVD General (EU MDR)
Ref K 7877CV
Identity
- Trade Name
- IDK® Bile Acids (cuvette version; Serum), photometric EUDAMED
- Device Name
- IDK® Bile Acids (cuvette version; Serum), photometric EUDAMED
- Model / Reference
- K 7877CV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598001725 EUDAMED
- Basic UDI-DI
- B-04050598001725 EUDAMED
- EMDN Code
- W01010202 BILE ACIDS EUDAMED
- Models / Variants
- IDK® Bile Acids (cuvette version EUDAMEDSerum), photometric EUDAMED
Classification
- Device Class
- Class IVD General 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
IDK® Bile Acids (cuvette version +1 more model by Immundiagnostik AG — Class IVD General — IVDD — listed in EUDAMED — 2 models — 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-04050598001725 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED f915179a-02e6-4ca6-9255-1f9ee56d05f1 61 fields · synced Jun 11, 2026