Identity
- Trade Name
- Compomax (B4) EUDAMED
- Device Name
- Dental Composite EUDAMED
- Model / Reference
- 8906170051113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906170051113 EUDAMED
- Basic UDI-DI
- 890617005B110CP0RX EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Category: Dental composite resin
Compomax (B4) by D Tech Dental Technologies — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 890617005B110CP0RX | Class IIa | Active |
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Manufacturer
- Manufacturer
- D Tech Dental Technologies
- EUDAMED SRN
- IN-MF-000024847
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 11c4ed82-5f4a-43cc-81dd-b7219997dc5c 61 fields · synced Jul 31, 2026