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Face Bow
EUDAMEDClass I (EU MDR)
Ref 5210-0083Model w/cuspid hooks, inner arch length :83mmRef 5210-0097Model w/cuspid hooks, inner arch length :97mmRef 5210-0111Model w/cuspid hooks, inner arch length :111mmRef 5210-0090Model w/cuspid hooks, inner arch length :90mm
Identity
- Device Name
- Face Bow EUDAMED
- Model / Reference
- w/cuspid hooks, inner arch length :83mm EUDAMED5210-0083 EUDAMEDw/cuspid hooks, inner arch length :97mm EUDAMED5210-0097 EUDAMEDw/cuspid hooks, inner arch length :111mm EUDAMED5210-0111 EUDAMEDw/cuspid hooks, inner arch length :90mm EUDAMED5210-0090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-5210-0083FY EUDAMEDD-5210-0097GB EUDAMEDD-5210-0111FC EUDAMEDD-5210-0090FV EUDAMED
- Basic UDI-DI
- B-5210-0083FY EUDAMEDB-5210-0097GB EUDAMEDB-5210-0111FC EUDAMEDB-5210-0090FV 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
Face Bow 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-5210-0083FY | 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 (4)
- EUDAMED 1c3e2811-ba0b-4093-a608-b52b2af0d73b 61 fields · synced Jul 18, 2026
- EUDAMED 7452723d-99c8-42ef-8f3a-a8665d83f3a7 61 fields · synced May 17, 2026
- EUDAMED 84e4211d-4b6d-4239-a6e1-5786f686cae4 61 fields · synced May 18, 2026
- EUDAMED 9df02f39-5009-48f9-b71f-2fd83ad74b05 61 fields · synced May 19, 2026