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DRI Creatinine-Detect Test
EUDAMEDClass IVD General (EU MDR)
Ref 100274Ref 100275Ref 100272
Identity
- Device Name
- DRI Creatinine-Detect Test EUDAMED
- Model / Reference
- 100274 EUDAMED100275 EUDAMED100272 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884883001787 EUDAMED00884883001794 EUDAMED00884883001763 EUDAMED
- Basic UDI-DI
- B-00884883001787 EUDAMEDB-00884883001794 EUDAMEDB-00884883001763 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
DRI Creatinine-Detect Test by Microgenics 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-00884883001787 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- EUDAMED SRN
- US-MF-000030375
- Authorised Representative
- B·R·A·H·M·S GmbH DE-AR-000026031
Sources (3)
- EUDAMED 603e9cdc-e0c7-4ed6-b415-383b07767157 61 fields · synced Jul 17, 2026
- EUDAMED 1fcf38a2-ae35-4cff-b3d6-f70d768b0d75 61 fields · synced May 18, 2026
- EUDAMED b3b78607-441e-4ea2-91a9-5b6318a19946 61 fields · synced May 18, 2026