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TRU-ARCH ALIGN SE200 UM 016X022 NiTi DIMPLE 10PK
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 227-3135
Identity
- Trade Name
- TRU-ARCH ALIGN SE200 UM 016X022 NiTi DIMPLE 10PK EUDAMEDTru-Arch Align FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- TRU-ARCH ALIGN SE200 UM 016X022 NiTi DIMPLE 10PK EUDAMEDFDA UDI
- Model / Reference
- 227-3135 EUDAMEDFDA UDI
- Description
- TRU-ARCH ALIGN SE200 UM 016X022 NiTi DIMPLE 10PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989032079 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989032079 EUDAMED
- FDA Product Code
- DZC FDA UDI
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
- GMDN Term
- Orthodontic archwire 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
TRU-ARCH ALIGN SE200 UM 016X022 NiTi DIMPLE 10PK 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-00889989032079 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED 352e5c70-2a97-4b9d-b1ac-47d0ea651ab2 61 fields · synced Jun 19, 2026
- FDA UDI dfcd4270-eb9c-455d-a7e8-5f52eefb9f45 35 fields · synced May 30, 2026