Identity
- Device Name
- Soufflette 3M AIR MEDICAL 8bars EUDAMED
- Model / Reference
- SOU/8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37604415501332 EUDAMED
- Basic UDI-DI
- 300379376044155013376 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 8bars 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 | 300379376044155013376 | Class I | Active |
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Manufacturer
- Manufacturer
- Dexther
- EUDAMED SRN
- FR-MF-000052364
Sources (1)
- EUDAMED 5ddae499-2e6a-4156-bb10-5fbd4595d43e 61 fields · synced Oct 8, 2026