Identity
- Trade Name
- ImproClot®Thrombelastograph EUDAMED
- Device Name
- Thrombelastograph EUDAMED
- Model / Reference
- T-400 EUDAMED310402000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974481833416 EUDAMED
- Basic UDI-DI
- 697448183010004V2 EUDAMED
- Direct Marketing DI
- 06974481833416 EUDAMED
- EMDN Code
- W0202020101 SEMI-AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
ImproClot®Thrombelastograph by Guangzhou Improve Medical Instruments 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 | 697448183010004V2 | Class A | Active |
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Manufacturer
- Manufacturer
- Guangzhou Improve Medical Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000006536
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 059bed5c-4498-467d-ae57-d495cd915498 61 fields · synced Jun 18, 2026