Identity
- Device Name
- Fully Auto Glycated Hemoglobin Analyzer EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975200380082 EUDAMED
- Basic UDI-DI
- 697520038H600BV EUDAMED
- Direct Marketing DI
- 06975200380082 EUDAMED
- EMDN Code
- W0201060101 GLYCOSILATED HEMOGLOBIN DEVICES 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
Fully Auto Glycated Hemoglobin Analyzer by Shenzhen Xilaiheng Medical Electronics 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 | 697520038H600BV | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Xilaiheng Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000047090
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED c1da3bc4-f8c8-4224-bcb4-5daa4c91dae9 61 fields · synced Jul 16, 2026