Identity
- Trade Name
- Erkoplast EUDAMED
- Device Name
- Erkoplast PLA-T, 3,00 mm, 125 x 125 mm, transparent EUDAMED
- Model / Reference
- Erkoplast EUDAMED562230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +ERKO5622301 EUDAMED
- Basic UDI-DI
- ++ERKO101NNNNN12095D EUDAMED
- Unit of Use DI
- 1 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Erkoplast by Erkodent Erich Kopp Gmbh — Class I — 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 | ++ERKO101NNNNN12095D | Class I | Active |
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Manufacturer
- Manufacturer
- Erkodent Erich Kopp GmbH
- EUDAMED SRN
- DE-MF-000006243
Sources (1)
- EUDAMED 542aca94-0f0a-4313-a407-de0ac36e12ef 61 fields · synced Jul 9, 2026