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Erkolign
EUDAMEDClass IIa (EU MDR)
Ref 541610Model ErkolignRef 541210Ref 541510Ref 541220Ref 544520Ref 544220
Identity
- Trade Name
- Erkolign EUDAMED
- Device Name
- Erkolign, 1,00 mm, Ø 120 mm, transparent EUDAMED
- Model / Reference
- Erkolign EUDAMED541610 EUDAMED541210 EUDAMED541510 EUDAMED541220 EUDAMED544520 EUDAMED544220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +ERKO5416102 EUDAMED+ERKO5412101 EUDAMED+ERKO5415101 EUDAMED+ERKO5412201 EUDAMED+ERKO5445202 EUDAMED+ERKO5442202 EUDAMED
- Basic UDI-DI
- ++ERKO042aNNNNN1209S3 EUDAMED
- Unit of Use DI
- 2 EUDAMED1 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 (6)
- EUDAMED e39be207-4dbd-4cee-a780-fb8d9c52811c 61 fields · synced Sep 18, 2026
- EUDAMED 98e7b186-7848-4ddd-b290-f2857f16b9fe 61 fields · synced May 17, 2026
- EUDAMED 94ee73cd-c0f5-490a-9fe6-a0c8d901fb64 61 fields · synced May 18, 2026
- EUDAMED 241b2cf2-c34a-47e1-9c1d-9d303f1c98f0 61 fields · synced May 18, 2026
- EUDAMED af95efcb-2337-424e-8097-d62638536933 61 fields · synced May 19, 2026
- EUDAMED 2eef4e53-3d5e-4005-a4c7-0bb5b5dbca02 61 fields · synced May 19, 2026