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Orthodontic Ceramic Bracket
EUDAMEDClass IIa (EU MDR)
Ref HTCT-01 Rev.6-8,9
by HT Co., Ltd.
Identity
- Device Name
- Orthodontic Ceramic Bracket EUDAMED
- Model / Reference
- HTCT-01 Rev.6-8,9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800022203548 EUDAMED
- Basic UDI-DI
- 880002220MisoSeriesDG 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
Orthodontic Ceramic Bracket by HT Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 880002220MisoSeriesDG | Class IIa | Active |
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Manufacturer
- Manufacturer
- HT Co., Ltd.
- EUDAMED SRN
- KR-MF-000011619
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 229297d1-6b8e-4f13-8b3f-2ff975fe5634 61 fields · synced Jun 5, 2026