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Prime|one Perfect Fit
EUDAMEDClass I (EU MDR)
Ref FAMPA24-AKZ-LI-K00Ref FAMPA24-AKZ-PI-K00Ref FAMPA24-AKZ-WH-K00
Identity
- Trade Name
- PRIME|ONE PERFECT FIT EUDAMED
- Device Name
- FACE MASKS EUDAMED
- Model / Reference
- FAMPA24-AKZ-LI-K00 EUDAMEDFAMPA24-AKZ-PI-K00 EUDAMEDFAMPA24-AKZ-WH-K00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476607135 EUDAMED04250476607159 EUDAMED04250476607173 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 EUDAMEDCzechia EUDAMEDAustria 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 Perfect Fit 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 a9043898-925f-4348-ab8a-84e9e082408e 61 fields · synced Oct 6, 2026
- EUDAMED 24fc27ec-37fc-46c5-afb9-541c47b4d15b 61 fields · synced May 16, 2026
- EUDAMED f918a92f-5c1d-4a82-a991-2e4a1e291bbe 61 fields · synced May 19, 2026