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Orthodontic Lingual Buttons
EUDAMEDClass IIa (EU MDR)
Ref 4340-02Ref 4700-01Ref 4340-03Ref 4330-00Ref 4600-01Ref 4370-00Ref 4380-00Ref TS11-55-345HRef 4340-05 Ref 4340-08LRef 4340-09Ref 4340-10
Identity
- Trade Name
- Xenium EUDAMED
- Device Name
- Orthodontic Lingual Buttons EUDAMEDOrthodontic Brackets EUDAMED
- Model / Reference
- 4340-02 EUDAMED4700-01 EUDAMED4340-03 EUDAMED4330-00 EUDAMED4600-01 EUDAMED4370-00 EUDAMED4380-00 EUDAMEDTS11-55-345H EUDAMED4340-05 EUDAMED4340-08L EUDAMED4340-09 EUDAMED4340-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973329326431 EUDAMED06973329326417 EUDAMED06973329326448 EUDAMED06941673545082 EUDAMED06973329326400 EUDAMED06973329326387 EUDAMED06973329326370 EUDAMED06941673551854 EUDAMED06941673548892 EUDAMED06941673552134 EUDAMED06941673552141 EUDAMED
- Basic UDI-DI
- 697332932BTN2932N9 EUDAMED69416735BTN735PQ EUDAMED69416735BRK735ND EUDAMED
- Direct Marketing DI
- 06973329326431 EUDAMED06973329326417 EUDAMED06973329326448 EUDAMED06941673545082 EUDAMED06973329326400 EUDAMED06973329326387 EUDAMED06973329326370 EUDAMED06941673551854 EUDAMED06941673548892 EUDAMED06941673552134 EUDAMED06941673552141 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS 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
Category: Orthodontic tube
Orthodontic Lingual Buttons by Astar Orthodontics Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697332932BTN2932N9 | 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 (12)
- EUDAMED f8ec9b31-3ae8-49b4-8eb9-bc36ae3462c6 61 fields · synced Sep 17, 2026
- EUDAMED 84c675f5-72bb-4228-a3f5-2843ae2c844b 61 fields · synced May 16, 2026
- EUDAMED b87d5513-2645-4dba-87fa-7b6db2d6d308 61 fields · synced May 16, 2026
- EUDAMED 9b9862c9-668d-448a-834f-3a60974565a5 61 fields · synced May 17, 2026
- EUDAMED d8d0c7d2-963f-4f2b-89f7-82c4f2129782 61 fields · synced May 17, 2026
- EUDAMED 70b009f9-2330-4f44-8d46-fa54ce2035bd 61 fields · synced May 17, 2026
- EUDAMED 6f58851f-5eec-425a-a00c-a7a5bec2e010 61 fields · synced May 18, 2026
- EUDAMED 70093a02-5fd7-4400-bcb5-f47b32692c85 61 fields · synced May 18, 2026
- EUDAMED e8c66902-0845-4a40-b1ec-19baab3b3c25 61 fields · synced May 19, 2026
- EUDAMED 41c9a613-3ec6-4a4a-82ef-32acb1af73fb 61 fields · synced Jul 10, 2026
- EUDAMED dd8201e4-1cd6-41d8-96f9-fd8c645cd4e5 61 fields · synced Jul 25, 2026
- EUDAMED db601c91-64cc-43f1-b090-3c839e853833 61 fields · synced Sep 17, 2026