Mini Master Series Tube
by American Orthodontics 183 variants
Ref 46LIPW
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number01907460000138DY 00190746145346 | Date4 Aug 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00190746145346 | Date19 Jul 2019 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Mini Master Series Tube EUDAMEDMini Master Series GUDID
- Generic Name
- Orthodontic tube
- Model / Ref / Catalog
- 46LIPW
- Primary DI / UDI-DI
- 00190746145346
- Basic UDI-DI
- 01907460000138DY
- FDA Product Code
- DZD
- EMDN Code
- Q010403 Orthodontic brackets and buttons
- GMDN Term
- Orthodontic tube
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 872.5410
- EU market of registration
- Netherlands
- GUDID distribution status
- 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
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
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Expiration Date: No