Identity
- Trade Name
- Orthodontic Brackets EUDAMED
- Device Name
- Orthodontic Brackets EUDAMED
- Model / Reference
- B11-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941985532404 EUDAMED
- Basic UDI-DI
- 69419855DTCTC1000133 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Orthodontic tube
Orthodontic Brackets by Hangzhou DTC Medical Apparatus Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic tube.
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- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69419855DTCTC1000133 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou DTC Medical Apparatus Co., Ltd
- EUDAMED SRN
- CN-MF-000032021
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9cc761eb-1302-4599-b3ee-b6a0fa03804f 61 fields · synced Jun 19, 2026