Invader PTCA
by Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. 36 variants
Ref 512110021646
Active
CE MDR
Valid until
3 Jul 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number086991955InvaderPTCAVA 08699195507566 | Date2 Apr 2025 | StatusActive |
Certificates
- 0425-MDR-006772-00 Active
Quality management system EU MDR
- Certifier
- ICIM S.P.A. 0425
- Issued
- 4 Jul 2023
- Expires
- 3 Jul 2028
- 0425-MDR-006773-00 Active
Technical documentation EU MDR
- Certifier
- ICIM S.P.A. 0425
- Issued
- 4 Jul 2023
- Expires
- 3 Jul 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Invader PTCA Balloon Dilatation Catheter
- Model / Reference
- 512110021646
- Primary DI / UDI-DI
- 08699195507566
- Basic UDI-DI
- 086991955InvaderPTCAVA
- Direct Marketing DI
- 08699195507566
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000029915
From the manufacturer
Manufacturer's product page: Balloon - Invader™ PTCA Improved Performance
Other devices from Alvimedica Tibbi Urunler San. ve Dis Tic. A.S.
See all devices from Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. →
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