Identity
- Device Name
- Vacuum forming sheets EUDAMED
- Model / Reference
- APLP0494 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 78981425852492 EUDAMED
- Basic UDI-DI
- 789814258placastermoforWQ EUDAMED
- Direct Marketing DI
- 78981425852492 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Vacuum forming sheets 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 | 789814258placastermoforWQ | 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 00b59a61-94c1-4a9f-9a4a-ef8461034627 61 fields · synced Jun 19, 2026