Single-patient-use instruments and accessories
Ref 141-0126-35
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
Single-patient-use instruments and accessories from LEONE S.P.A., a leading manufacturer of medical devices. These instruments are designed for single use, making them ideal for patients requiring specific care. With advanced technology and innovative designs, these devices offer superior performance and user experience.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number080337070TDI003VK 08033707102779 | Date5 Dec 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- Withdrawn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
- Model / Reference
- 141-0126-35
- Primary DI / UDI-DI
- 08033707102779
- Basic UDI-DI
- 080337070TDI003VK
- EMDN Code
- Q01020199 Dental impression materials - other
- Device Class
- Class I
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000005986
Other devices from Leone S.P.A.
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