Identity
- Trade Name
- septaline disposable mask EUDAMED
- Device Name
- GANT EUDAMED
- Model / Reference
- I9014DPI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700425948013 EUDAMED
- Basic UDI-DI
- 03700425NS-classI-001VZ EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 disposable mask by Medistock — 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 | 03700425NS-classI-001VZ | Class I | Active |
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Manufacturer
- Manufacturer
- Medistock
- EUDAMED SRN
- FR-MF-000007667
Sources (1)
- EUDAMED e0fee8bf-286a-462c-afb2-f8ccc9028eb8 61 fields · synced Jun 14, 2026