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Total protein (Biuret Reagent)
EUDAMEDClass IVD General (EU MDR)
Ref D-638 001Ref D-638 002
Identity
- Trade Name
- Total protein (Biuret Reagent) EUDAMED
- Device Name
- Total protein (Biuret Reagent) EUDAMED
- Model / Reference
- D-638 001 EUDAMEDD-638 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182704162 EUDAMED62230182704230 EUDAMED
- Basic UDI-DI
- B-62230182704162 EUDAMEDB-62230182704230 EUDAMED
- EMDN Code
- W01010230 TOTAL PROTEIN 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 protein (Biuret Reagent) by Kalians Corporation — Class IVD General — IVDD — listed in EUDAMED — 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-62230182704162 | 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 (2)
- EUDAMED 23034925-e94e-4399-9517-8f9de47815b3 61 fields · synced Jul 27, 2026
- EUDAMED 475703d4-12b9-49c8-a26e-12def71c4906 61 fields · synced May 18, 2026