SAUER-Fußgängerbeutel, 0, 6 l, Schiebehahn, gestufter Adapter, aufsteckbar, Schlauch 45 cm, kürzbar, Rücklaufventil, Viskose-Beschichtung
by Manfred Sauer GmbH 3 variants
Ref 710.2445-10
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
For medical professionals, the Sauer-Fußgängerbeutel (Urinary Bead) is a Class I medical device designed for the temporary and reversible collection of urine. The device features a unique gestured adapter, adjustable cuff, and retractable nozzle, making it an ideal tool for various medical procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number42502745000004EE 04250274501116 | Date14 Oct 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- Withdrawn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
- Urinbeutel
- Model / Reference
- 710.2445-10
- Primary DI / UDI-DI
- 04250274501116
- Basic UDI-DI
- 42502745000004EE
- EMDN Code
- A06030301 Urine collection bags
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006287
Other devices from Manfred Sauer GmbH
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