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Ultrasafe Top Mask
EUDAMEDClass I (EU MDR)
Ref FAMAA52-AKZ-LI-K02Ref FAMAA52-AKZ-WH-K02Ref FAMAA52-AKZ-FG-K02Ref FAMAA52-AKZ-FU-K02
Identity
- Trade Name
- ULTRASAFE TOP MASK EUDAMED
- Device Name
- FACE MASKS EUDAMED
- Model / Reference
- FAMAA52-AKZ-LI-K02 EUDAMEDFAMAA52-AKZ-WH-K02 EUDAMEDFAMAA52-AKZ-FG-K02 EUDAMEDFAMAA52-AKZ-FU-K02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476618933 EUDAMED04250476618995 EUDAMED04250476618971 EUDAMED04250476618216 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
- Denmark EUDAMEDSweden EUDAMEDRomania EUDAMEDHungary 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
Ultrasafe Top Mask 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 (4)
- EUDAMED cca392bb-6fac-4679-b093-e6dbf79f2261 61 fields · synced Jul 30, 2026
- EUDAMED 2a03a12a-4c1b-4ec5-b3af-4b34a69b4576 61 fields · synced May 18, 2026
- EUDAMED 45469f1b-88b6-40a8-b3ca-031f83adf6a0 61 fields · synced May 18, 2026
- EUDAMED e0b0bd8e-c5c6-4cd2-a4e4-657f771a506c 61 fields · synced May 18, 2026