Identity
- Trade Name
- ORTHODONTIC BUCCAL TUBES EUDAMED
- Device Name
- ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- Model / Reference
- ET-401-236 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932622906146 EUDAMED
- Basic UDI-DI
- 697476625EKS012PF 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 Buccal Tubes by Zhejiang Eksen Medical Technology 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 | 697476625EKS012PF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Eksen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000034903
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 0691c5ef-b1b5-4259-b921-54d135786e80 61 fields · synced Jul 8, 2026