Identity
- Device Name
- ESR Fast Detector EUDAMED
- Model / Reference
- 521010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974481833192 EUDAMED
- Basic UDI-DI
- 697448183020001V7 EUDAMED
- EMDN Code
- W01030107 ERYTHROCYTE SEDIMENTATION RATE (ESR) TEST 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
No
EUDAMED
New Device
No
EUDAMED
ESR Fast Detector 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 | 697448183020001V7 | 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 b4420899-1311-4867-a3fb-2ae8d07c6791 61 fields · synced Jul 9, 2026