Invader PTCA
by Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. 37 variants
Part of a family of 37 devices: see the family page
Ref 512110021526
Invader PTCA (512110021526) is a Class III device made by Alvimedica Tibbi Urunler San. ve Dis Tic. A.S., registered in EUDAMED on 2 Apr 2025 (Basic UDI-DI 086991955InvaderPTCAVA) with CE/MDR certificate 0425-MDR-006772-00 valid until 3 Jul 2028, active as of 22 Oct 2026.
Active
Valid until
3 Jul 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number086991955InvaderPTCAVA 08699195505449 | Date2 Apr 2025 | StatusActive |
Official records
- EUDAMED public site 086991955InvaderPTCAVA
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
Timeline
- Certificate issued EUDAMED 0425-MDR-006772-00
- Certificate issued EUDAMED 0425-MDR-006773-00
- Registered EUDAMED 086991955InvaderPTCAVA
- Certificate expires EUDAMED 0425-MDR-006772-00
- Certificate expires EUDAMED 0425-MDR-006773-00
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Invader PTCA Balloon Dilatation Catheter
- Model / reference
- 512110021526
- Primary DI / UDI-DI
- 08699195505449
- Basic UDI-DI
- 086991955InvaderPTCAVA
- Direct marketing DI
- 08699195505449
- EMDN code
- C010401020101 Ptca balloon dilation catheters
- Device class
- Class III
- System or procedure pack
- Procedure pack which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000029915
From the manufacturer
Manufacturer's product page: Balloon - Invader™ PTCA Improved Performance
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