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Reverse Pull Headgear(Face Mask)
EUDAMEDClass I (EU MDR)
Ref 5268-5002Model Middle, BlueRef 5268-5001Model Middle, Red
Identity
- Device Name
- Reverse Pull Headgear(Face Mask) EUDAMED
- Model / Reference
- Middle, Blue EUDAMED5268-5002 EUDAMEDMiddle, Red EUDAMED5268-5001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5268-5002N6 EUDAMEDD-5268-5001N4 EUDAMED
- Basic UDI-DI
- B-5268-5002N6 EUDAMEDB-5268-5001N4 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
Reverse Pull Headgear(Face Mask) 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-5268-5002N6 | 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 be15d3e6-a10f-4975-b276-62bcbcfff6af 61 fields · synced Jul 24, 2026
- EUDAMED c9d3af6c-d274-434c-bb93-65c125e6947d 61 fields · synced May 18, 2026