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Total Bilirubin (Single Reagent) MODIFIED BERGH & MÜLLER METHOD
EUDAMEDClass IVD General (EU MDR)
Ref D-610 003Ref D-610 002Ref D-610 001
Identity
- Trade Name
- Total Bilirubin (Single Reagent) MODIFIED BERGH & MÜLLER METHOD EUDAMED
- Device Name
- Total Bilirubin (Single Reagent) MODIFIED BERGH & MÜLLER METHOD EUDAMED
- Model / Reference
- D-610 003 EUDAMEDD-610 002 EUDAMEDD-610 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182703936 EUDAMED62230182703868 EUDAMED62230182703790 EUDAMED
- Basic UDI-DI
- B-62230182703936 EUDAMEDB-62230182703868 EUDAMEDB-62230182703790 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN 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
Total Bilirubin (Single Reagent) MODIFIED BERGH & MÜLLER METHOD by Kalians Corporation — Class IVD General — IVDD — listed in EUDAMED
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-62230182703936 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED f392a5f6-e1e8-4d5c-aafa-8e6c99bab07c 61 fields · synced Jul 21, 2026
- EUDAMED 394674fa-416a-41e8-8601-64b4bc5e04f9 61 fields · synced May 18, 2026
- EUDAMED 5013be82-6084-46a5-b514-1c14ad1e6e98 61 fields · synced May 19, 2026