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Prime|one Cool Breath
EUDAMEDClass I (EU MDR)
Ref FAMDA24-AKZ-LI-K00Ref FAMDA24-AKZ-BL-K00Ref FAMDA24-AKZ-PI-K00
Identity
- Trade Name
- PRIME|ONE COOL BREATH EUDAMED
- Device Name
- FACE MASKS EUDAMED
- Model / Reference
- FAMDA24-AKZ-LI-K00 EUDAMEDFAMDA24-AKZ-BL-K00 EUDAMEDFAMDA24-AKZ-PI-K00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476603267 EUDAMED04250476606893 EUDAMED04250476607012 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
- Netherlands EUDAMEDSweden 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
Prime|one Cool Breath 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 90e8d05a-71cf-4c64-9791-b36394c960cd 61 fields · synced Oct 6, 2026
- EUDAMED 5cca29cf-5365-4ea4-83d7-71f0d4c8a83f 61 fields · synced May 17, 2026
- EUDAMED 328f2370-0d68-46b0-9aed-33b4b34f5199 61 fields · synced May 19, 2026