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Urea/BUN – (UV)(4+1)
EUDAMEDClass IVD General (EU MDR)
Ref D-641 001Ref D-641 004
Identity
- Trade Name
- Urea/BUN – (UV)(4+1) EUDAMED
- Device Name
- Urea/BUN – (UV)(4+1) EUDAMED
- Model / Reference
- D-641 001 EUDAMEDD-641 004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182705534 EUDAMED62230182705848 EUDAMED
- Basic UDI-DI
- B-62230182705534 EUDAMEDB-62230182705848 EUDAMED
- EMDN Code
- W01010204 UREA/BLOOD UREA NITROGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Urea/BUN – (UV)(4+1) 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-62230182705534 | 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 771e8c0d-e52c-440d-b319-4f6b2b6d8125 61 fields · synced Jul 29, 2026
- EUDAMED cb6b3850-221d-489e-af40-13633b0d712a 61 fields · synced May 17, 2026