Promedon
by Promedon S.A. Argentina EUDAMED
Ref KIT-UNITAPE-T PLUS
EMDN U070101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number812180FSL3323LPEZF | Date22 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- IZ 1620741-1 Issued
Technical documentation EU MDR
- Notified body
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 18 Mar 2026
- Expires
- 17 Mar 2031
Specification
- Device Name
- Unitape T Plus
- Model / Reference
- KIT-UNITAPE-T PLUS
- Primary DI / UDI-DI
- 07798121804838
- Basic UDI-DI
- 812180FSL3323LPEZF
- EMDN Code
- U070101 Sling systems for the treatment of incontinence
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- AR-MF-000023348
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Promedon S.A.
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 4f2c0ed0-77c7-44c2-8981-628b5bb1efbd