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Creatinine - Jaffè
EUDAMEDClass IVD General (EU MDR)
Ref D-619 001Ref D-619 003Ref D-618 002
Identity
- Trade Name
- Creatinine - Jaffè EUDAMEDCreatinine - Jaffè (Single Reagent) EUDAMED
- Device Name
- Creatinine - Jaffè EUDAMEDCreatinine - Jaffè (Single Reagent) EUDAMED
- Model / Reference
- D-619 001 EUDAMEDD-619 003 EUDAMEDD-618 002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182702328 EUDAMED62230182702564 EUDAMED62230182702250 EUDAMED
- Basic UDI-DI
- B-62230182702328 EUDAMEDB-62230182702564 EUDAMEDB-62230182702250 EUDAMED
- EMDN Code
- W01010207 CREATININE 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
Creatinine - Jaffè 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-62230182702328 | 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 9f7bfa80-b83e-4407-9b0e-f301c5289d77 61 fields · synced Jul 27, 2026
- EUDAMED 5ed0b0fd-1019-4f72-bf49-97dd5aa8a5d2 61 fields · synced May 17, 2026
- EUDAMED a8f20b23-8003-4806-8e45-75a83bed747d 61 fields · synced May 18, 2026