Ureteral Access Sheath
by Hunan Reborn Medical Science and Technology Development Co., Ltd 190 variants
Model CS10/12F,YS10/2FCS11/3Fr,YS113FCS1244FLYS1214FrCS13/15FYS13/15F.CS14/16FYYS14/16FrCS18/20FrYS18/20FrCS20/22FrYS20/2 2FrCS2224FrYS22/24FrRef RB UAS FYS11/13Fr×(250), RB UAS BS10/12Fr×(500), RB UAS FYS14/16Fr×(360)
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-CNMF000023648UASU0299XX | Date31 Jul 2024 | 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- Withdrawn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
- Model / Reference
- CS10/12F, YS10/2FCS11/3Fr, YS113FCS1244FLYS1214FrCS13/15FYS13/15F.CS14/16FYYS14/16FrCS18/20FrYS18/20FrCS20/22FrYS20/2 2FrCS2224FrYS22/24Fr, RB UAS FYS11/13Fr×(250), RB UAS BS10/12Fr×(500), RB UAS FYS14/16Fr×(360)
- Primary DI / UDI-DI
- D-CNMF000023648UASU0299XX, 06959956550555, 06959956560233, 06959956550944
- Basic UDI-DI
- B-CNMF000023648UASU0299XX, 69599565UASDF
- EMDN Code
- U0299 Ureteral catheters - other
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000023648
- Authorised representative
- MedPath GmbH DE-AR-000000087
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Properties
Other properties (12)
- 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