Tray - Ø 90x50 mm
by Fábrica de Artefatos Metalúrgicos Itá Ltda.
Ref 231.014
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number78995245PBRS6X 07898412948446 | Date30 Jan 2024 | 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- Withdrawn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
- Device name
- FAMI Processing Basket for the Versius Ultrasonic Dissector Transducer
- Model / reference
- 231.014
- Primary DI / UDI-DI
- 07898412948446
- Basic UDI-DI
- 78995245PBRS6X
- Direct marketing DI
- 07898412948446
- EMDN code
- S010401 Trays, baskets, tubs for sterilisation and their components
- Device class
- Class I
- System or procedure pack
- Procedure pack which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Northern Ireland
Manufacturer details
- EUDAMED SRN
- BR-MF-000039534
- Authorised representative
- Easy Medical Device CommV BE-AR-000011902
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Properties
Other properties (13)
- Supplied sterile: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No