Identity
- Trade Name
- Vision Cart EUDAMED
- Device Name
- Vision Cart EUDAMED
- Model / Reference
- CM2101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070997281 EUDAMED
- Basic UDI-DI
- 697507099VC000KB EUDAMED
- Direct Marketing DI
- 06975070997281 EUDAMED
- EMDN Code
- Z12029003 ENDOSCOPE TRANSPORT CARTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vision Cart by Shenzhen Edge Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697507099VC000KB | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Edge Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000039045
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 344556c7-7f16-4cd0-adb0-56818566a225 61 fields · synced Jul 30, 2026