GenTek®
by Zfx GmbH EUDAMED
Active
Ref ZFX05I-ZB-CE-34
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number42518817-GT-I-Scanbody-J2 | Date13 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- GenTek® Intraoral Scanbody
- Model / Reference
- ZFX05I-ZB-CE-34
- Primary DI / UDI-DI
- 04251881768503
- Basic UDI-DI
- 42518817-GT-I-Scanbody-J2
- EMDN Code
- Q01010199 Dental restoration devices - other
- Device Class
- Class I
Manufacturer details
- EUDAMED SRN
- DE-MF-000018101
Other devices from Zfx GmbH
Properties
Other properties (13)
- Sterile: No
- Implantable: 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