Identity
- Trade Name
- Erkolign EUDAMED
- Device Name
- Erkolign, 1,00 mm, Ø 120 mm, transparent EUDAMED
- Model / Reference
- Erkolign EUDAMED544510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +ERKO5445102 EUDAMED
- Basic UDI-DI
- ++ERKO042aNNNNN1209S3 EUDAMED
- Unit of Use DI
- 2 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Erkolign by Erkodent Erich Kopp 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 | ++ERKO042aNNNNN1209S3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Erkodent Erich Kopp GmbH
- EUDAMED SRN
- DE-MF-000006243
Sources (1)
- EUDAMED 4bb3f960-367a-43f7-98df-da0989ee886a 61 fields · synced Jun 18, 2026