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Digital Angiography System
EUDAMEDClass IIb (EU MDR)
Ref N/AModel CGO-5200 Pro, CGO-2100 Plus
Identity
- Device Name
- Digital Angiography System EUDAMED
- Model / Reference
- CGO-5200 Pro, CGO-2100 Plus EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938964314113 EUDAMED
- Basic UDI-DI
- 693896431400NH EUDAMED
- EMDN Code
- Z11030102 STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Digital Angiography System by Beijing Wandong Medical Technology Co., Ltd. — Class IIb — 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 | 693896431400NH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing Wandong Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014174
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED d584b28f-7daf-42ec-8624-93bb23d2b171-1 61 fields · synced Jun 18, 2026
- EUDAMED d584b28f-7daf-42ec-8624-93bb23d2b171-2 61 fields · synced Jun 18, 2026