← Back to catalogue
Astar
EUDAMEDClass I (EU MDR)
Ref 5268-4000Model FrameRef 5268-5004Model Middle, Orange
Identity
- Trade Name
- ASTAR EUDAMED
- Device Name
- Reverse Pull Headgear(Face Mask) EUDAMED
- Model / Reference
- Frame EUDAMED5268-4000 EUDAMEDMiddle, Orange EUDAMED5268-5004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5268-4000MT EUDAMEDD-5268-5004NA EUDAMED
- Basic UDI-DI
- B-5268-4000MT EUDAMEDB-5268-5004NA 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
Astar 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-5268-4000MT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Astar Orthodontics Inc.
- EUDAMED SRN
- CN-MF-000028647
- Authorised Representative
- BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480
Sources (2)
- EUDAMED 9c1235e5-9c6c-4b8a-ae51-2af426a62562 61 fields · synced Jul 21, 2026
- EUDAMED 7fe9b555-0795-47f0-8b2b-5d82a886b894 61 fields · synced May 18, 2026