IH Temporary Abutment
by SEWONMEDIX Inc. 16 variants
Ref AIHTARH4510DModel IH IMPLANT SYSTEM
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800041350339 | Date4 Jun 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / Reference
- IH IMPLANT SYSTEM, AIHTARH4510D
- Primary DI / UDI-DI
- 08800041350339
- Basic UDI-DI
- B-08800041350339
- EMDN Code
- P01020101 Dental implants
- Device Class
- Class IIb
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- KR-MF-000016194
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from SEWONMEDIX Inc.
Properties
Other properties (10)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No