Identity
- Trade Name
- OmniDispenser 1:1 EUDAMED
- Device Name
- Mischpistole für Kartuschensysteme EUDAMED
- Model / Reference
- DIOMNIGUN1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260044630014 EUDAMED
- Basic UDI-DI
- 42600446300555 EUDAMED
- Direct Marketing DI
- 04260044630014 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
OmniDispenser 1:1 by Zantomed 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 | 42600446300555 | Class I | Active |
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Manufacturer
- Manufacturer
- Zantomed GmbH
- EUDAMED SRN
- DE-MF-000009550
Sources (1)
- EUDAMED 889027a5-d4d0-4987-84d6-8e3751ac5508 61 fields · synced Jul 10, 2026