ASAHI Gaia Next 1
by Asahi Intecc Co., Ltd. 3 variants
Ref AH14R019P
Active
CE MDR
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 |
Certificates
- 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
- 4202096TD01 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 25 Aug 2023
- Expires
- 25 Aug 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- ASAHI Gaia Next
- Model / Reference
- AH14R019P
- Primary DI / UDI-DI
- 04547327116824
- Basic UDI-DI
- 4547327DGW001NX
- EMDN Code
- C04010201 Coronary artery therapeutic guidewires, hydrophilic
- 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