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Smart|one
EUDAMEDClass I (EU MDR)
Ref FAMAA24-AKZ-MB-K02Ref FAMBA24-AKZ-BL-K01Ref FAMAA24-AKZ-WH-K02Ref GLOBN51-AKZ-LA-S01Ref FAMAA24-AKZ-HO-K02Ref GLOBN51-AKZ-IB-XS1Ref GLOBN51-AKZ-LA-XS1Ref FAMAA24-AKZ-TL-K02Ref FAMAA24-AKZ-BL-K02Ref FAMAA24-AKZ-GR-K02Ref GLOBN51-AKZ-LA-M01Ref FAMAA24-AKZ-FU-K02Ref FAMAA24-AKZ-PI-K02Ref GLOFL29-AKZ-WH-M01Ref GLOBN51-AKZ-WH-M01Ref GLOBN51-AKZ-WH-S01
Identity
- Trade Name
- SMART|ONE EUDAMED
- Device Name
- FACE MASKS EUDAMEDGLOVES EUDAMED
- Model / Reference
- FAMAA24-AKZ-MB-K02 EUDAMEDFAMBA24-AKZ-BL-K01 EUDAMEDFAMAA24-AKZ-WH-K02 EUDAMEDGLOBN51-AKZ-LA-S01 EUDAMEDFAMAA24-AKZ-HO-K02 EUDAMEDGLOBN51-AKZ-IB-XS1 EUDAMEDGLOBN51-AKZ-LA-XS1 EUDAMEDFAMAA24-AKZ-TL-K02 EUDAMEDFAMAA24-AKZ-BL-K02 EUDAMEDFAMAA24-AKZ-GR-K02 EUDAMEDGLOBN51-AKZ-LA-M01 EUDAMEDFAMAA24-AKZ-FU-K02 EUDAMEDFAMAA24-AKZ-PI-K02 EUDAMEDGLOFL29-AKZ-WH-M01 EUDAMEDGLOBN51-AKZ-WH-M01 EUDAMEDGLOBN51-AKZ-WH-S01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476621575 EUDAMED04250476612771 EUDAMED04250476620493 EUDAMED04250476643645 EUDAMED04250476621599 EUDAMED04250476645243 EUDAMED04250476643638 EUDAMED04250476618117 EUDAMED04250476620516 EUDAMED04250476620530 EUDAMED04250476643652 EUDAMED04250476622985 EUDAMED04250476620752 EUDAMED04250476642778 EUDAMED04250476643737 EUDAMED04250476643720 EUDAMED
- Basic UDI-DI
- 42504766FAMTD EUDAMED42504766GLOUP EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMEDT01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMEDT010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMEDSweden EUDAMEDCroatia EUDAMEDSpain EUDAMEDIreland EUDAMEDCzechia EUDAMEDPoland EUDAMEDItaly EUDAMEDAustria EUDAMEDHungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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 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 (16)
- EUDAMED 759c1536-2f4c-4923-835a-ad09da85f559 61 fields · synced Oct 6, 2026
- EUDAMED f065d877-cfe3-4052-877c-25e523fac33f 61 fields · synced May 16, 2026
- EUDAMED 5643789b-ba95-4061-a402-3bdee1018201 61 fields · synced May 17, 2026
- EUDAMED a91b32f6-52e0-46d0-9d6c-e632adcbc0fb 61 fields · synced May 17, 2026
- EUDAMED 2f8d8852-0306-4051-a626-3a85f7d84ae8 61 fields · synced May 17, 2026
- EUDAMED 99250f62-a68d-4334-b399-032d8b5372e1 61 fields · synced May 17, 2026
- EUDAMED f0e9c5ed-bcdf-4016-98b8-5317abd0f5cf 61 fields · synced May 17, 2026
- EUDAMED 14effe85-ffeb-47b7-8559-70124dd83f46 61 fields · synced May 18, 2026
- EUDAMED 3cf62a20-bcc0-4c4a-bfac-1f4b20c4a91d 61 fields · synced May 18, 2026
- EUDAMED f24f2ecc-ee5c-44c2-8493-f6e40800459f 61 fields · synced May 18, 2026
- EUDAMED 7277be1d-6e31-456c-9770-790cbb75da71 61 fields · synced May 19, 2026
- EUDAMED dd592178-bc71-4fbe-96c7-532aad204720 61 fields · synced May 19, 2026
- EUDAMED 795dfdd4-77c4-4a5b-a456-af07c6dfc2c6 61 fields · synced May 19, 2026
- EUDAMED 95b667d1-aeda-43ed-a397-b7d44f52cfd6 61 fields · synced Jul 16, 2026
- EUDAMED 6f7bcbc7-618c-4823-8b04-004037e6d1b8 61 fields · synced Jul 28, 2026
- EUDAMED 6eed9562-ac82-4819-90a0-3332e85a54b7 61 fields · synced Sep 18, 2026