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Diluent Universal
EUDAMEDClass A (EU MDR)
Ref KR-DU-01200Ref KR-DU-0120Ref KR-DU-0140
Identity
- Trade Name
- Diluent Universal EUDAMED
- Device Name
- Diluent Universal EUDAMED
- Model / Reference
- KR-DU-01200 EUDAMEDKR-DU-0120 EUDAMEDKR-DU-0140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973600794027 EUDAMED06973600799008 EUDAMED06973600796359 EUDAMED
- Basic UDI-DI
- 697360079004JP EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
New Device
No
EUDAMED
Diluent Universal by Xiamen Innodx Biotech Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697360079004JP | Class A | 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 6e5281f4-fe16-43c2-83fd-8b396e094b4d 61 fields · synced Oct 7, 2026
- EUDAMED 61b59d8b-96de-4ba0-800d-9635a8ad68c9 61 fields · synced May 17, 2026
- EUDAMED 9060bc18-f68d-49b8-84ab-bc5921774838 61 fields · synced May 19, 2026