ASAHI PTCA Guide Wire ASAHI SION 300cm J
Ref AHW14R301J
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-04547327086219 04547327086219 | Date22 Dec 2025 | StatusActive |
Certificates
- 4202096TD09 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 26 Sep 2025
- Expires
- 26 Sep 2030
- 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- Withdrawn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 ASAHI SION 300cm JSion
- Device Name
- ASAHI PTCA Guide Wire ASAHI SION and SUOH 03PCI Guide Wire SION PCI Guide Wire SION blue PCI Guide Wire SION black PCI Guide Wire SION blue ES PCI Guide Wire SUOH 03
- Model / Reference
- AHW14R301J
- Primary DI / UDI-DI
- 04547327086219
- Basic UDI-DI
- B-04547327086219, 4547327BGW011N8
- 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