Giant S-AT Balloon Catheter
by Scitech Produtos Médicos SA EUDAMED
Active
Ref 128937Model GIANT S-AT BALLOON CATHETER
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number79082497GIANTVD | Date23 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-MDR/QS-016 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 7 Feb 2025
- Expires
- 7 Feb 2030
- 2025-MDR/TD-016 Issued
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 7 Feb 2025
- Expires
- 7 Feb 2030
Specification
- Device Name
- Peripheral Angioplasty Balloon Catheter
- Model / Reference
- GIANT S-AT BALLOON CATHETER, 128937
- Primary DI / UDI-DI
- 07908249704242
- Basic UDI-DI
- 79082497GIANTVD
- EMDN Code
- C010402020101 PTA balloon dilatation catheters
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- BR-MF-000018627
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Scitech Produtos Médicos SA
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