Spreader ø0.5mm Hollow Handle 6mm
Ref 102-494
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 | Number4251891SPREADERSQH 42518911031038 | Date14 Mar 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- Withdrawn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
- Spreaders
- Model / Reference
- 102-494
- Primary DI / UDI-DI
- 42518911031038
- Basic UDI-DI
- 4251891SPREADERSQH
- Direct Marketing DI
- 42518911031038
- EMDN Code
- L159012 Endodontic spreaders and pluggers, reusable
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- PK-MF-000019554
- Authorised representative
- AR Instrumed Deutschland GmbH DE-AR-000014821
Other devices from AR Instrumed
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