Identity
- Trade Name
- DEHP EUDAMED
- Device Name
- Glas Ionomer Cements EUDAMED
- Model / Reference
- TF-083 (DEHP) EUDAMED9795734 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04062183035589 EUDAMED
- Basic UDI-DI
- B-04062183035589 EUDAMED
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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: Glass ionomer dental cement
Dehp by CB Healthcare Consulting GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Glass ionomer dental cement.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04062183035589 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CB Healthcare Consulting GmbH
- EUDAMED SRN
- DE-MF-000005902
Sources (1)
- EUDAMED 1cc04190-910a-4b2b-a71b-2b9efce6a24b 61 fields · synced Oct 7, 2026