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Endoscopic Image System
EUDAMEDClass I (EU MDR)
Ref U400Model U400、U400-A 、U400-B 、U500 、U500-A 、U500-B
Identity
- Device Name
- Endoscopic Image System EUDAMED
- Model / Reference
- U400、U400-A 、U400-B 、U500 、U500-A 、U500-B EUDAMEDU400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975202770256 EUDAMED
- Basic UDI-DI
- 697520277003J3 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
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Endoscopic Image System by Hunan Endoso Life Technology 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 | 697520277003J3 | Class I | Active |
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Manufacturer
- Manufacturer
- Hunan Endoso Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000021400
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 5378d1f9-4a89-435b-abf9-8b5abec77c4b 61 fields · synced Jun 18, 2026