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CEDIA Gentamicin II Assay (125 tests)
EUDAMEDClass IVD General (EU MDR)
Ref 09086137190
Identity
- Device Name
- CEDIA Gentamicin II Assay (125 tests) EUDAMED
- Model / Reference
- 09086137190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613336190753 EUDAMED
- Basic UDI-DI
- B-07613336190753 EUDAMED
- EMDN Code
- W0102080307 GENTAMICIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
CEDIA Gentamicin II Assay (125 tests) 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-07613336190753 | 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 (1)
- EUDAMED 088e4bb9-1cac-42c5-8d87-1f41580baca5 61 fields · synced Jul 28, 2026