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Orthodontic Lingual Retainer
EUDAMEDClass IIa (EU MDR)
Ref 4401-38Ref 4403-26Ref 4403-22Ref 4401-47Ref 4401-45Ref 4800-00Ref 4401-42Ref 4403-24
Identity
- Device Name
- Orthodontic Lingual Retainer EUDAMED
- Model / Reference
- 4401-38 EUDAMED4403-26 EUDAMED4403-22 EUDAMED4401-47 EUDAMED4401-45 EUDAMED4800-00 EUDAMED4401-42 EUDAMED4403-24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973329326462 EUDAMED06973329326585 EUDAMED06973329326561 EUDAMED06973329326509 EUDAMED06973329326493 EUDAMED06941673545303 EUDAMED06973329326486 EUDAMED06973329326578 EUDAMED
- Basic UDI-DI
- 697332932LR2932FS EUDAMED69416735LR735Q9 EUDAMED
- Direct Marketing DI
- 06973329326462 EUDAMED06973329326585 EUDAMED06973329326561 EUDAMED06973329326509 EUDAMED06973329326493 EUDAMED06941673545303 EUDAMED06973329326486 EUDAMED06973329326578 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 Retainer 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 | 697332932LR2932FS | 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 (8)
- EUDAMED 8f302c44-cace-459c-b671-50ebe6192589 61 fields · synced Aug 4, 2026
- EUDAMED 09e23c90-467e-435f-b09f-441b80b880fd 61 fields · synced May 16, 2026
- EUDAMED e5bd6ffb-e6ef-4511-a0d8-79ea01a56870 61 fields · synced May 16, 2026
- EUDAMED 625df1a1-9a67-4a1b-87bd-32c60b9b6368 61 fields · synced May 18, 2026
- EUDAMED 06e7c8a0-f062-4193-b246-29329cc50a33 61 fields · synced May 18, 2026
- EUDAMED 1118ad79-2bf4-42c1-adfa-140a4dc8d672 61 fields · synced May 18, 2026
- EUDAMED f396dba0-9c25-43f9-8e11-34edfaa02d5b 61 fields · synced May 18, 2026
- EUDAMED 5afef6bc-cd00-4b4d-9ba2-d9c10e9df623 61 fields · synced May 19, 2026