Scan Gauge Kit
by Implant solutions Pty Ltd (T/A Osteon Medical) 31 variants
Ref SGKAFModel SGK
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++D102SGKQ5 +D102SGKAF0 | Date17 Nov 2022 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Scan Gauge Kit
- Model / Reference
- SGK, SGKAF
- Primary DI / UDI-DI
- +D102SGKAF0
- Basic UDI-DI
- ++D102SGKQ5
- Direct Marketing DI
- +D102SGKAF0
- EMDN Code
- Q010280 Prosthetic dentistry devices - accessories
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- AU-MF-000030323
- Authorised representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Other devices from Implant solutions Pty Ltd (T/A Osteon Medical)
See all devices from Implant solutions Pty Ltd (T/A Osteon Medical) →
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