RealFit I
by US Orthodontic Products United States EUDAMED
Ref B1102-343Model Orthodontic Bands
EMDN Q010402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number08428351B16Z | Date15 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 27 countries, as listed in EUDAMED:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
Specification
- Model / Reference
- Orthodontic Bands, B1102-343
- Primary DI / UDI-DI
- 00842835116668
- Basic UDI-DI
- 08428351B16Z
- EMDN Code
- Q010402 Orthodontic bands
- Device Class
- Class IIa
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- US-MF-000038151
- Authorised representative
- EC Certification Service GmbH AT-AR-000006658
Other devices from US Orthodontic Products
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 00842835116668|08428351B16Z