Identity
- Trade Name
- DD base P HI 98H20 gingiva 3 EUDAMED
- Device Name
- DD medical polymers 1209 EUDAMED
- Model / Reference
- K50820 EUDAMED
Identifiers
- Primary DI / UDI-DI
- EDDIK508201 EUDAMED
- Basic UDI-DI
- ++EDDIPOLYMER1209IIARC EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
DD base P HI 98H20 gingiva 3 by Dental Direkt GmbH — Class IIa — 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 | ++EDDIPOLYMER1209IIARC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dental Direkt GmbH
- EUDAMED SRN
- DE-MF-000006592
Sources (1)
- EUDAMED f7a2d6fb-9352-49cb-8047-66b7fd84503b 61 fields · synced Sep 17, 2026