SHENYUN MEDICAL Sterile Single Use Urinary Catheter
by Suzhou Shenyun Medical Equipment Co., Ltd. 18 variants
Ref SCT 10FR
Active
CE MDR
Valid until
22 Oct 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6975573320099D6 06975573323037 | Date10 Nov 2025 | StatusActive |
Certificates
- CN25/00007163 Active
Quality assurance EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 22 Oct 2025
- Expires
- 22 Oct 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sterile Single Use Urinary Catheter
- Model / Reference
- SCT 10FR
- Primary DI / UDI-DI
- 06975573323037
- Basic UDI-DI
- 6975573320099D6
- EMDN Code
- U070201 Sheath catheter for the treatment of incontinence
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000026847
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Suzhou Shenyun Medical Equipment Co., Ltd.
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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