Identity
- Trade Name
- Orthodontic - Wachssticks neutral (weiß) EUDAMED
- Device Name
- Orthodontic Wachse EUDAMED
- Model / Reference
- 80600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EBER80600 EUDAMED
- Basic UDI-DI
- 426075024OrthodonticRM 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
Orthodontic - Wachssticks neutral (weiß) by Karl Berg 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 | 426075024OrthodonticRM | Class I | Active |
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Manufacturer
- Manufacturer
- Karl Berg GmbH
- EUDAMED SRN
- DE-MF-000005811
Sources (1)
- EUDAMED 7efb6120-9a3c-446e-a7a9-f015324e3642 61 fields · synced Jul 11, 2026