Identity
- Device Name
- TDR ONE-96 EUDAMED
- Model / Reference
- 105-009393-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938010901922 EUDAMED
- Basic UDI-DI
- B-06938010901922 EUDAMED
- EMDN Code
- W0104080109 COMBINED SUSCEPTIBILITY AND IDENTIFICATION SYSTEMS GRAM NEGATIVES - AUTOMATED EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Cyprus 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
Tdr One-96 by Hunan Mindray Medical Technology Co., Ltd. — 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-06938010901922 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hunan Mindray Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022479
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fa5dd1cb-cd31-44e4-950d-4fd4502cb679 61 fields · synced Oct 6, 2026