Identity
- Trade Name
- BISSWAELLE VORGEFORMT ROT EUDAMED
- Device Name
- Dentalwachse EUDAMED
- Model / Reference
- DBSH0050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D991DB0501H EUDAMED
- Basic UDI-DI
- ++D991DW82435NG 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
Bisswaelle Vorgeformt Rot by MORSA Wachswarenfabrik Sallinger GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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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 | ++D991DW82435NG | Class I | Active |
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Manufacturer
- Manufacturer
- MORSA Wachswarenfabrik Sallinger GmbH
- EUDAMED SRN
- DE-MF-000028586
Sources (1)
- EUDAMED 17f24505-6c24-4dfc-b34c-f3039b0dc8b0 61 fields · synced Oct 6, 2026