Identity
- Trade Name
- Erkodur-A2 EUDAMED
- Device Name
- Erkodur, 1,00 mm, Ø 120 mm, klar EUDAMED
- Model / Reference
- Erkodur EUDAMED520210 EUDAMED520206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +ERKO5202102 EUDAMED+ERKO5202062 EUDAMED
- Basic UDI-DI
- ++ERKO022aNNNNN1209PR 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
Erkodur-A2 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 | ++ERKO022aNNNNN1209PR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Erkodent Erich Kopp GmbH
- EUDAMED SRN
- DE-MF-000006243
Sources (2)
- EUDAMED 32a49de7-a493-40dc-b79e-8ab2ac287b6c 61 fields · synced Jul 23, 2026
- EUDAMED ae41d0fd-5490-4c9e-ae83-c688cbbf42ec 61 fields · synced May 18, 2026