Non-sterile urine bags
by Produtos Médicos Hospitalares, SA 12 variants
Ref 401.3813, 404.4866, 402.0804, 401.0512, 404.3939, 403.0540, 404.0792Model 401.0507
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 | Number5607716400IS8 | Date27 Apr 2026 | 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- Withdrawn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
- Non-sterile urine bags
- Model / Reference
- 401.0507, 401.3813, 404.4866, 402.0804, 401.0512, 404.3939, 403.0540, 404.0792
- Primary DI / UDI-DI
- 05607716038133, 05607716048668, 05607716008044, 05607716005128, 05607716039390, 05607716005401, 05607716007924, 05607716005074
- Basic UDI-DI
- 5607716400IS8
- EMDN Code
- A06030301 Urine collection bags
- Device Class
- Class I
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- PT-MF-000007631
Other devices from Produtos Médicos Hospitalares, SA
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