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Orthodontic Appliances
EUDAMEDClass I (EU MDR)
Ref Movable OrthosisModel Bow Expansion Orthosis, Movable OrthosisRef 001
Identity
- Trade Name
- Orthodontic Appliances EUDAMED
- Device Name
- Orthodontic Appliances EUDAMED
- Model / Reference
- Bow Expansion Orthosis, Movable Orthosis EUDAMEDMovable Orthosis EUDAMED001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16977687550023 EUDAMED16977687550016 EUDAMED
- Basic UDI-DI
- 697768755001SW EUDAMED
- EMDN Code
- Q010401 ORTHODONTIC FACE BOWS EUDAMED
Classification
- Device Class
- Class I 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 Appliances by Sichuan Artistan Medical Science & Technology Co., Ltd. — Class I — 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 | 697768755001SW | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000042901
- Authorised Representative
- WISELINK MEDICAL, S.L.U. ES-AR-000052118
Sources (2)
- EUDAMED 32e97a0e-d4ca-4361-951d-00cf1b68df95 61 fields · synced Jul 18, 2026
- EUDAMED 2a408f50-1bab-405b-aed3-d5a4fcf12783 61 fields · synced May 19, 2026