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Video Colonoscope
EUDAMEDClass IIa (EU MDR)
Ref /Model CVE-2900HT/CVE-2900HL/CVE-2900HI/CVE-2900HS/CVE-3000HT/CVE-3000HL/CVE-3000HI/CVE-3000HTW/CVE-3000HLW/CVE-3000HIW/CVE-3500HT/CVE-3500HL/CVE-3500HI/CVE-3500HS
Identity
- Device Name
- Video Colonoscope EUDAMED
- Model / Reference
- CVE-2900HT/CVE-2900HL/CVE-2900HI/CVE-2900HS/CVE-3000HT/CVE-3000HL/CVE-3000HI/CVE-3000HTW/CVE-3000HLW/CVE-3000HIW/CVE-3500HT/CVE-3500HL/CVE-3500HI/CVE-3500HS EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953393165174 EUDAMED
- Basic UDI-DI
- 69533931COFS EUDAMED
- EMDN Code
- Z12020606 VIDEO COLONOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Video Colonoscope by HUGER Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69533931COFS | Class IIa | Unknown |
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Manufacturer
- Manufacturer
- HUGER Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001128
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9a97708d-4244-4d57-9a6c-b0a9a4dab967 61 fields · synced Jun 18, 2026