Identity
- Trade Name
- OptoMedic 4K UHD Medical Monitor EUDAMED
- Device Name
- OptoMedic 4K UHD Medical Monitor EUDAMED
- Model / Reference
- OPTO-2U55WA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973031299252 EUDAMED
- Basic UDI-DI
- 697303129WS0901F7 EUDAMED
- Direct Marketing DI
- 06973031299252 EUDAMED
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
OptoMedic 4K UHD Medical Monitor by Guangdong Optomedic Technologies, Inc. — 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 | 697303129WS0901F7 | Class I | Active |
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Manufacturer
- Manufacturer
- Guangdong Optomedic Technologies, Inc.
- EUDAMED SRN
- CN-MF-000011588
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 4c004ffa-bbf9-41d8-b22b-cc9cd0424289 61 fields · synced Oct 6, 2026