Tanzo
by American Orthodontics United States EUDAMEDGUDID
Ref 833-VS-1725
Product code DZCEMDN Q010405
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number01907460000227DY | Date1 Aug 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00190746064463 | Date20 Oct 2017 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Orthodontic wire
- Model / Ref / Catalog
- 833-VS-1725
- Primary DI / UDI-DI
- 00190746064463
- Basic UDI-DI
- 01907460000227DY
- FDA Product Code
- DZC
- EMDN Code
- Q010405 Orthodontic wires
- GMDN Term
- Orthodontic wire
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 872.5410
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- US-MF-000007702
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from American Orthodontics
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- 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
- Over-the-Counter: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
Sources (2)
- EUDAMED a8ef63b6-783e-410e-b5d3-d546126ed716
- FDA UDI 3a66de11-6332-4110-9079-1b4fd03237d3