Urinary Catheters for Single Use (Foley)
by Haiyan Kangyuan Medical Instrument Co., Ltd. 194 variants
Ref 01/11/14/10Model Two-Way, Three-Way; Normal Balloon, Integral Flat Balloon; Nelaton Tip, Tiemann Tip
Active
CE MDR
Valid until
1 Feb 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6948097001DNGGN 06948097050437 | Date23 Apr 2025 | StatusActive |
Certificates
- 6122159CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 10 Apr 2025
- Expires
- 1 Feb 2028
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Urinary Catheters for Single Use (Foley)
- Model / Reference
- Two-Way, Three-Way, Normal Balloon, Integral Flat Balloon, Nelaton Tip, Tiemann Tip, 01/11/14/10
- Primary DI / UDI-DI
- 06948097050437
- Basic UDI-DI
- 6948097001DNGGN
- EMDN Code
- U020299 Ureteral catheters with balloon - other
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000001532
- Authorised representative
- Eunitor GmbH DE-AR-000005081
Other devices from Haiyan Kangyuan Medical Instrument 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