TiGEN Abutment
by MegaGen Implant Co., Ltd. 312 variants
Ref OSTGMR1512.MTN
Active
CE MDR
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/MDR | Number880972899103PP 08809822764440 | Date12 Jul 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- TiGEN Abutment
- Model / Reference
- OSTGMR1512.MTN
- Primary DI / UDI-DI
- 08809822764440
- Basic UDI-DI
- 880972899103PP
- EMDN Code
- P01020101 Dental implants
- Device Class
- Class IIb
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- KR-MF-000009885
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Megagen Implant Co., Ltd.
Properties
Other properties (12)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No