Identity
- Device Name
- Magnifying Lens EUDAMED
- Model / Reference
- ALUP0637 EUDAMEDALUP0421 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 78981425847788 EUDAMED78981425870458 EUDAMED
- Basic UDI-DI
- 789814258Lupa67 EUDAMED
- Direct Marketing DI
- 78981425847788 EUDAMED78981425870458 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Magnifying Lens 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 | 789814258Lupa67 | 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 f6c941bd-4aa3-4129-bfd0-944236513bca 61 fields · synced Jul 25, 2026
- EUDAMED 2636fe71-6965-4db1-82b3-1cebb4d21a6b 61 fields · synced May 18, 2026