PENTAX VIDEO COLONOSCOPE EC-3890Zi SERIES
by PENTAX Medical Corporation 4 variants
Ref 04580826922022Model EC-3890LZi
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-04580826922022 04580826922022 | Date28 Nov 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- PENTAX VIDEO COLONOSCOPE EC-3890Zi SERIES EC-3890LZi
- Model / Reference
- EC-3890LZi, 04580826922022
- Primary DI / UDI-DI
- 04580826922022
- Basic UDI-DI
- B-04580826922022
- EMDN Code
- Z12020606 Video colonoscopes
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- JP-MF-000005227
- Authorised representative
- PENTAX Europe GmbH DE-AR-000000006
Other devices from PENTAX Medical Corporation
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No