Silicone Foley Catheters with Temperature probe for Single Use
by Haiyan Kangyuan Medical Instrument Co., Ltd. EUDAMED
Active
Ref /
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06948097052721 | Date30 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- Silicone Foley Catheters with Temperature probe for Single Use
- Model / Reference
- /
- Primary DI / UDI-DI
- 06948097052721
- Basic UDI-DI
- B-06948097052721
- EMDN Code
- U0103 Urethral prostatic and bladder catheters with temperature sensors
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000001532
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
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Properties
Other properties (9)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No