Endoscope Washer-Disinfectors
by Choyang Medical Industry Ltd. 6 variants
Ref CYCLEAN
Active
CE MDR
Valid until
4 Sep 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88001257CYCLEANM8 08800125700005 | Date25 Jun 2026 | StatusActive |
Certificates
- KR25/00000099 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 4 Sep 2025
- Expires
- 4 Sep 2030
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Endoscope Washer-Disinfectors
- Model / Reference
- CYCLEAN
- Primary DI / UDI-DI
- 08800125700005
- Basic UDI-DI
- 88001257CYCLEANM8
- Direct Marketing DI
- 08800125700005
- EMDN Code
- V0799 Products for cleaning medical devices not included in other classes - other
- Device Class
- Class IIb
Manufacturer details
- EUDAMED SRN
- KR-MF-000026280
- Authorised representative
- Javitech Consulting GmbH DE-AR-000045915
Other devices from Choyang Medical Industry Ltd.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No