Identity
- Device Name
- Soufflette 3M AIR MEDICAL 4bars EUDAMED
- Model / Reference
- SOU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37604415501264 EUDAMED
- Basic UDI-DI
- 300379376044155012679 EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT 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
Category: Surgical utensil washer/disinfector
Soufflette 3M AIR MEDICAL 4bars by Dexther — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 300379376044155012679 | Class I | Active |
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Manufacturer
- Manufacturer
- Dexther
- EUDAMED SRN
- FR-MF-000052364
Sources (1)
- EUDAMED 9cec220c-05ad-41ed-9a71-22e3e8dda470 61 fields · synced Oct 6, 2026