Root Elevator Anatomic Handle
by Seven Eight Sirgikal 2 variants
Ref R-322-00
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 | Number++G276ROOTELEVATORSDA +G276R322000K | Date15 Jul 2022 | 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- Withdrawn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
- Dental Root Elevator
- Model / Reference
- R-322-00
- Primary DI / UDI-DI
- +G276R322000K
- Basic UDI-DI
- ++G276ROOTELEVATORSDA
- Direct Marketing DI
- +G276R322000K
- EMDN Code
- L15900899 Dental equipment tips not included in other classes, reusable - other
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- PK-MF-000009959
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Seven Eight Sirgikal
Properties
Other properties (12)
- Sterile: No
- Implantable: 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