← Back to catalogue
Endoscopic Image System
EUDAMEDClass I (EU MDR)
Ref HD2000-C1-NModel HD2000-C1、HD2000-C1-NRef U400-AModel U400、U400-A 、U400-B 、U500 、U500-A 、U500-BRef U500Ref HD2000-C1Ref U400-BRef U500-A
Identity
- Device Name
- Endoscopic Image System EUDAMED
- Model / Reference
- HD2000-C1、HD2000-C1-N EUDAMEDHD2000-C1-N EUDAMEDU400、U400-A 、U400-B 、U500 、U500-A 、U500-B EUDAMEDU400-A EUDAMEDU500 EUDAMEDHD2000-C1 EUDAMEDU400-B EUDAMEDU500-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975202770270 EUDAMED06975202770539 EUDAMED06975202770553 EUDAMED06975202770263 EUDAMED06975202770546 EUDAMED06975202770560 EUDAMED
- Basic UDI-DI
- 697520277001HX EUDAMED697520277003J3 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 | 697520277001HX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hunan Endoso Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000021400
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (6)
- EUDAMED 3f59a38e-b6ec-4778-9f8b-5eb72395fddb 61 fields · synced Jul 22, 2026
- EUDAMED 735ce1cd-f499-402f-a45e-b119d4604cb4 61 fields · synced May 11, 2026
- EUDAMED b094e980-f1e1-414f-84a0-462efee30e67 61 fields · synced May 16, 2026
- EUDAMED 65400632-a085-44b7-b612-94902e7ac269 61 fields · synced May 18, 2026
- EUDAMED dbf70958-1a4b-421d-8cc2-6531849e5419 61 fields · synced May 18, 2026
- EUDAMED ad6b1d4e-ec73-4f85-8aae-170ef8901e0e 61 fields · synced May 19, 2026