Identity
- Trade Name
- Simplee Mixing Gun 1:1/2:1 EUDAMED
- Device Name
- Mischpistole für Kartuschensysteme EUDAMED
- Model / Reference
- 156219 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260044630403 EUDAMED
- Basic UDI-DI
- 42600446300555 EUDAMED
- Direct Marketing DI
- 04260044630403 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
Simplee Mixing Gun 1:1/2:1 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 1c8a8bc9-71a6-439e-8073-69170e3cf7b1 61 fields · synced Jul 23, 2026