Identity
- Trade Name
- Nordema GIC Filling Plus EUDAMED
- Device Name
- Nordema GIC Filling Plus EUDAMED
- Model / Reference
- 8562 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D92685621 EUDAMED
- Basic UDI-DI
- ++D9260206000000000S8 EUDAMED
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER 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: Dental composite resin
Nordema GIC Filling Plus by Nordema GmbH — 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 | ++D9260206000000000S8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nordema GmbH
- EUDAMED SRN
- DE-MF-000008684
Sources (1)
- EUDAMED 3714c0c4-1483-4d11-aa9e-c190fba42c95 61 fields · synced Oct 6, 2026