Identity
- Device Name
- Toothless Fork EUDAMED
- Model / Reference
- AGDE0495 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 78981425839318 EUDAMED
- Basic UDI-DI
- 789814258garfosarcoC4 EUDAMED
- Direct Marketing DI
- 78981425839318 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Luxembourg EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Toothless Fork 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 | 789814258garfosarcoC4 | 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 (1)
- EUDAMED be57ee70-e6e0-4811-8edd-e71ccad0263d 61 fields · synced Jun 17, 2026