Identity
- Device Name
- Elite Face-Bow EUDAMED
- Model / Reference
- AACP0452 EUDAMEDAACS0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 78981425837260 EUDAMED78981425830230 EUDAMED
- Basic UDI-DI
- 789814258ArcofacialAZ EUDAMED
- Direct Marketing DI
- 78981425837260 EUDAMED78981425830230 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Elite Face-Bow by Bio-Art Equipamentos Odontológicos Ltda. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 789814258ArcofacialAZ | Class I | Active |
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Manufacturer
- Manufacturer
- Bio-Art Equipamentos Odontológicos Ltda.
- EUDAMED SRN
- BR-MF-000013642
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED a7c2aa0d-1d96-42ff-bb83-32a33fd1b82e 61 fields · synced Jul 19, 2026
- EUDAMED c5ce13eb-2076-4713-ad3e-73735554708e 61 fields · synced May 18, 2026