← Back to catalogue
U2r Minitwin Db/Mtwin 18 Andrews 9/3 Bhk
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 328-1220
Identity
- Trade Name
- U2R MINITWIN DB/MTWIN 18 ANDREWS 9/3 BHK EUDAMEDMini-Twin FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- U2R MINITWIN DB/MTWIN 18 ANDREWS 9/3 BHK EUDAMEDU2R MINI TWIN DB/MTWIN 18 ANDREWS 9/3 BHK FDA UDI
- Model / Reference
- 328-1220 EUDAMEDFDA UDI
- Description
- U2R MINI TWIN DB/MTWIN 18 ANDREWS 9/3 BHK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989035544 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989035544 EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
U2r Minitwin Db/Mtwin 18 Andrews 9/3 Bhk by Ormco Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00889989035544 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED adcd141b-43b3-4e7d-8c5c-1198ad2994ac 61 fields · synced Sep 17, 2026
- FDA UDI 7db5432b-b5a9-4f8c-a1b3-bf5ebc3e250b 35 fields · synced May 30, 2026