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Extraoral Headgears
EUDAMEDClass I (EU MDR)
Ref 5221-0000Model Cervical Headgear KitRef 5231-0000Model High pull Headgears Kit
Identity
- Device Name
- Extraoral Headgears EUDAMED
- Model / Reference
- Cervical Headgear Kit EUDAMED5221-0000 EUDAMEDHigh pull Headgears Kit EUDAMED5231-0000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5221-0000FY EUDAMEDD-5231-0000GH EUDAMED
- Basic UDI-DI
- B-5221-0000FY EUDAMEDB-5231-0000GH EUDAMED
- EMDN Code
- Q010401 ORTHODONTIC FACE BOWS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Extraoral Headgears by Astar Orthodontics Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-5221-0000FY | Class I | 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 (2)
- EUDAMED af1e4596-4145-4f67-bb7e-7cbb3da5ef89 61 fields · synced Jul 19, 2026
- EUDAMED 1b5eb576-1322-484a-9027-00cc5f1ff974 61 fields · synced May 17, 2026