AMECATH Urodynamic Catheter Kit
by Ameco medical industries EUDAMED
Active
Ref UD-2-07-J-KDModel As attached in the Declaration of Conformity
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6221139URO-UDC-2aRT | Date28 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Model / Reference
- As attached in the Declaration of Conformity, UD-2-07-J-KD
- Primary DI / UDI-DI
- 06221139282325
- Basic UDI-DI
- 6221139URO-UDC-2aRT
- Direct Marketing DI
- 06221139282325
- EMDN Code
- U0599 Urodynamics devices - other
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- EG-MF-000028383
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Ameco Medical Industries
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