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Smart|one Essential
EUDAMEDClass I (EU MDR)
Ref FAMEA24-AKZ-BL-K02Ref FAMEA24-AKZ-PI-K02Ref FAMEA24-AKZ-WH-K02
Identity
- Trade Name
- SMART|ONE ESSENTIAL EUDAMED
- Device Name
- FACE MASKS EUDAMED
- Model / Reference
- FAMEA24-AKZ-BL-K02 EUDAMEDFAMEA24-AKZ-PI-K02 EUDAMEDFAMEA24-AKZ-WH-K02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476626525 EUDAMED04250476626563 EUDAMED04250476626549 EUDAMED
- Basic UDI-DI
- 42504766FAMTD EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Smart|one Essential by Akzenta International SA — 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 | 42504766FAMTD | Class I | Active |
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Manufacturer
- Manufacturer
- Akzenta International SA
- EUDAMED SRN
- CH-MF-000036434
- Authorised Representative
- IQX GmbH AT-AR-000016713
Sources (3)
- EUDAMED cf806bc7-639d-4d6f-bc7f-e22e18105ef0 61 fields · synced Jul 19, 2026
- EUDAMED 5766277b-c9b8-43e3-bf7c-0ae1e4d4698e 61 fields · synced May 17, 2026
- EUDAMED 9a516d99-ab68-4ce9-96b1-a984a2e11170 61 fields · synced May 17, 2026