Screw Analog
by Dentium Co., Ltd. 2 variants
Ref GSAN43
Screw Analog (GSAN43) is a Class I device made by Dentium Co., Ltd., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI 880969136DENTIUM005Q9), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number880969136DENTIUM005Q9 08809544906814 | Date2 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 880969136DENTIUM005Q9
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- Withdrawn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
- Adapters, drivers and wrench
- Model / reference
- GSAN43
- Primary DI / UDI-DI
- 08809544906814
- Basic UDI-DI
- 880969136DENTIUM005Q9
- EMDN code
- Q010207 Dental impression devices for prosthetic dentistry
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Hungary
Manufacturer details
- EUDAMED SRN
- KR-MF-000023279
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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