Orthodontic Elastics
by Innovative Material and Devices, Inc 71 variants
Ref 51-205-04
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number693694923501-3961VR 06937382878511 | Date27 Apr 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- Withdrawn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
- Ligature Tie 1040 pcs/bag, Metallic Purple
- Model / reference
- 51-205-04
- Primary DI / UDI-DI
- 06937382878511
- Basic UDI-DI
- 693694923501-3961VR
- EMDN code
- Q010404 Orthodontic elastics, chains and springs
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000002280
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Innovative Material and Devices, Inc
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