Identity
- Trade Name
- Light Guide Bundles EUDAMED
- Device Name
- Endoscope Illuminator, Light Guide Bundles EUDAMED
- Model / Reference
- CM1811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070993009 EUDAMED
- Basic UDI-DI
- 697507099EI000ES EUDAMED
- EMDN Code
- Z12020480 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES 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
Light Guide Bundles 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 | 697507099EI000ES | 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 dfa6b7e1-de46-4f06-88f1-49d2a2ac23a9 61 fields · synced Jun 19, 2026