Identity
- Trade Name
- Wax bite rim EUDAMED
- Device Name
- Wachsbisswälle gebogen, hart, rosa-opak EUDAMED
- Model / Reference
- Wax bite rim EUDAMED756200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +ERKO7562001 EUDAMED
- Basic UDI-DI
- ++ERKO161NNNNN1209B7 EUDAMED
- Unit of Use DI
- 1 EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - 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
Category: Silicone dental impression material
Wax bite rim by Erkodent Erich Kopp Gmbh — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++ERKO161NNNNN1209B7 | Class I | Active |
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Manufacturer
- Manufacturer
- Erkodent Erich Kopp GmbH
- EUDAMED SRN
- DE-MF-000006243
Sources (1)
- EUDAMED 39cf1a88-5310-48d5-97b6-cf667ca007ee 61 fields · synced Jun 17, 2026