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Innodx Tb-Igra Cmia
EUDAMEDClass C (EU MDR)
Ref KR-TB-IGRA-01050WRef KR-TB-IGRA-01020C
Identity
- Trade Name
- INNODX TB-IGRA CMIA EUDAMED
- Device Name
- INNODX TB-IGRA CMIA EUDAMED
- Model / Reference
- KR-TB-IGRA-01050W EUDAMEDKR-TB-IGRA-01020C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600799831 EUDAMED06973600799824 EUDAMEDD-KR-TB-IGRA-01050W7U EUDAMED
- Basic UDI-DI
- 697360079019K4 EUDAMEDB-KR-TB-IGRA-01050W7U EUDAMED
- EMDN Code
- W0105010704 TB-IGRA (INTERFERON-GAMMA-RELEASE ASSAY) EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
Innodx Tb-Igra Cmia by Xiamen Innodx Biotech Co., Ltd. — Class C — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 697360079019K4 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 697360079019K4 | Class C | Active |
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Manufacturer
- Manufacturer
- Xiamen Innodx Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000041071
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED 161f93ee-e093-4602-9988-d64ae35b7146 61 fields · synced Oct 6, 2026
- EUDAMED a5949be9-4fba-4e89-a6c4-2d00578b9b2b 61 fields · synced May 18, 2026
- EUDAMED bb4ed1ce-7bfb-4374-91ce-5d9a0b0cfcb4 61 fields · synced Jul 14, 2026