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Orthodontic Lingual Sheaths
EUDAMEDClass IIa (EU MDR)
Ref 4120-02Ref 4120-03Ref 4130-11
Identity
- Device Name
- Orthodontic Lingual Sheaths EUDAMED
- Model / Reference
- 4120-02 EUDAMED4120-03 EUDAMED4130-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973329326295 EUDAMED06973329326301 EUDAMED06973329326325 EUDAMED
- Basic UDI-DI
- 697332932LS2932G5 EUDAMED69416735LS735QG EUDAMED
- Direct Marketing DI
- 06973329326295 EUDAMED06973329326301 EUDAMED06973329326325 EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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 Lingual Sheaths by Astar Orthodontics Inc. — 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 | 697332932LS2932G5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Astar Orthodontics Inc.
- EUDAMED SRN
- CN-MF-000028647
- Authorised Representative
- BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480
Sources (3)
- EUDAMED 5a83d6db-3647-4e1c-9a0b-f2531419d7c3 61 fields · synced Sep 17, 2026
- EUDAMED 39e6c8c6-d1a0-4249-a2c6-d66acd862434 61 fields · synced May 18, 2026
- EUDAMED 4414e9c0-bd5f-4425-bf55-a072b4b4528f 61 fields · synced May 19, 2026