Memory Chain
by American Orthodontics EUDAMEDGUDID
Active
Ref 854-252
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number01907460000236DZ | Date13 Feb 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00190746147869 | Date20 Sep 2019 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- Orthodontic inter-bracket elastic chain
- Model / Ref / Catalog
- 854-252
- Primary DI / UDI-DI
- 00190746147869
- Basic UDI-DI
- 01907460000236DZ
- FDA Product Code
- ECI
- EMDN Code
- Q010404 Orthodontic elastics, chains and springs
- GMDN Term
- Orthodontic inter-bracket elastic chain
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 872.5410
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
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
- Manufacturing Date: No