ASAHI PTCA Guide Wire CONFIANZA PRO 12
Ref AGH143091
Active
CE MDR CE MDD
Valid until
25 Aug 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4202096CE01 | Date15 May 2026 | StatusActive |
| European Union | CE/MDD | NumberB-04547327085441 04547327085441 | Date22 Dec 2025 | StatusActive |
Certificates
- 4202096TD06 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 26 Sep 2024
- Expires
- 1 Sep 2029
- 4202096CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 15 May 2026
- Expires
- 25 Aug 2028
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- ASAHI PTCA Guide Wire CONFIANZA PRO 12Confianza Pro 12
- Device Name
- ASAHI PTCA GUIDE WIRE, ASAHI PTCA Guide WireASAHI Conquest Pro PCI Guide Wire, Confianza Pro PCI Guide Wire, ASAHI Conquest Pro 12 PCI Guide Wire, Confianza Pro 12 PCI Guide Wire
- Model / Reference
- AGH143091
- Primary DI / UDI-DI
- 04547327085441
- Basic UDI-DI
- B-04547327085441, 4547327BGW008NK
- EMDN Code
- C04030201, C04010201
- Device Class
- Class III
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- JP-MF-000010199
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Asahi Intecc Co., Ltd.
Properties
Other properties (11)
- Implantable: No
- 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