Urinary Sheath
by Housen Medical lndustrial Co., Ltd 65 variants
Ref STANDARD33Model STANDARD18, STANDARD20, STANDARD24, STANDARD25, STANDARD28, STANDARD29, STANDARD30, STANDARD31, STANDARD32, STANDARD33, STANDARD35, STANDARD36, STANDARD40, STANDARD41,etc.
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697687808US001WB 06976878080106 | Date31 Jul 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Urinary Sheath
- Model / Reference
- STANDARD18, STANDARD20, STANDARD24, STANDARD25, STANDARD28, STANDARD29, STANDARD30, STANDARD31, STANDARD32, STANDARD33, STANDARD35, STANDARD36, STANDARD40, STANDARD41, etc.
- Primary DI / UDI-DI
- 06976878080106
- Basic UDI-DI
- 697687808US001WB
- EMDN Code
- A06030301 Urine collection bags
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048899
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Housen Medical lndustrial Co., Ltd
Properties
Other properties (13)
- Sterile: No
- 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