← Back to catalogue
Toothless Fork
EUDAMEDClass I (EU MDR)
Ref AGDE0062Ref AGCT0061Ref AGDS0001Ref AGDE0459
Identity
- Device Name
- Toothless Fork EUDAMED
- Model / Reference
- AGDE0062 EUDAMEDAGCT0061 EUDAMEDAGDS0001 EUDAMEDAGDE0459 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 78981425831084 EUDAMED78981425830926 EUDAMED78981425814940 EUDAMED78981425837710 EUDAMED
- Basic UDI-DI
- 789814258garfosarcoC4 EUDAMED
- Direct Marketing DI
- 78981425831084 EUDAMED78981425830926 EUDAMED78981425814940 EUDAMED78981425837710 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDRomania EUDAMEDHungary EUDAMEDGreece 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Art Equipamentos Odontológicos Ltda.
- EUDAMED SRN
- BR-MF-000013642
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED ffd3b3ee-e398-48de-a9f9-2930d683f633 61 fields · synced Jul 29, 2026
- EUDAMED f05eb6c5-38e4-4e0e-a40e-1f8448de8fc3 61 fields · synced May 17, 2026
- EUDAMED 103d2625-5af6-40dd-a5b2-04de74149656 61 fields · synced May 17, 2026
- EUDAMED 3b1cbee2-8af9-4af0-9bb1-c4b86cbf0a43 61 fields · synced May 17, 2026