Dental Root Elevators
by M.A. Arain and Brothers (Pvt) Ltd. 3 variants
Ref 01-004-00, 01-006-00, 01-005-00, 01-001-00, 01-006-07
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++G127DentalRootElevRUM3 | Date17 Aug 2023 | 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- Withdrawn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 Elevators
- Model / Reference
- 01-004-00, 01-006-00, 01-005-00, 01-001-00, 01-006-07
- Primary DI / UDI-DI
- *+G12701004000T*, *G12701006000V*, *+G12701005000U*, *+G12701001000Q*, *+G12701006070-*
- Basic UDI-DI
- ++G127DentalRootElevRUM3
- EMDN Code
- Q0199 Odontology devices - other
- Device Class
- Class I
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- PK-MF-000012289
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from M.A. Arain and Brothers (Pvt) Ltd.
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