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Septaline Utility Cool spray
EUDAMEDClass I (EU MDR)
Ref 33X.106Model 350
by PRISMAN GmbH
Identity
- Trade Name
- Septaline Utility Cool spray EUDAMED
- Device Name
- Kältespray CLASSIC EUDAMED
- Model / Reference
- 350 EUDAMED33X.106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064797028834 EUDAMED
- Basic UDI-DI
- ++EPRM350A4E EUDAMED
- Direct Marketing DI
- 04064797028834 EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - 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
Septaline Utility Cool spray by PRISMAN 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 | ++EPRM350A4E | Class I | Active |
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Manufacturer
- Manufacturer
- PRISMAN GmbH
- EUDAMED SRN
- DE-MF-000009900
Sources (1)
- EUDAMED ba2682df-982d-4030-be9c-a8c364e69e07 61 fields · synced Jun 19, 2026