← Back to catalogue
KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA)
EUDAMEDClass IVD General (EU MDR)
Ref 211045-20-01
Identity
- Trade Name
- KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) EUDAMED
- Device Name
- KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) EUDAMED
- Model / Reference
- 211045-20-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974167891860 EUDAMED
- Basic UDI-DI
- B-06974167891860 EUDAMED
- EMDN Code
- W0104080506 TARGETED RESISTANCE TESTS - CARBAPENEMASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) by Jiangsu Medomics Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06974167891860 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangsu Medomics Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030226
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (1)
- EUDAMED 96ae6d7d-b48c-40bc-be19-27d6b6e8d437 61 fields · synced Jul 17, 2026