SION black
by Asahi Intecc Co., Ltd. United States EUDAMED
Ref APW14R210S
EMDN C04010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4547327BGW011N8 | Date5 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 4202096TD09 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 26 Sep 2025
- Expires
- 26 Sep 2030
- 4202096CE01 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 15 May 2026
- Expires
- 25 Aug 2028
- Reason
- Add device or group
Specification
- Device Name
- PCI 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
- APW14R210S
- Primary DI / UDI-DI
- 04547327144339
- Basic UDI-DI
- 4547327BGW011N8
- EMDN Code
- C04010201 Coronary artery therapeutic guidewires, hydrophilic
- Device Class
- Class III
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 04547327144339|4547327BGW011N8