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Apto® F01 Full Face Mask Large
EUDAMEDClass IIa (EU MDR)
Ref 009974Model Apto® F01 Full Face MaskRef 009974
Identity
- Trade Name
- Apto® F01 Full Face Mask Large EUDAMED
- Device Name
- Apto® F01 Full Face Mask EUDAMED
- Model / Reference
- Apto® F01 Full Face Mask EUDAMED009974 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07321820099740 EUDAMED
- Basic UDI-DI
- 732182209999BA EUDAMED73218202099997 EUDAMED
- EMDN Code
- R0301010201,R0301010202 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Apto® F01 Full Face Mask Large by Breas Medical AB — Class IIa — 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 | 732182209999BA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Breas Medical AB
- EUDAMED SRN
- SE-MF-000001061
Sources (2)
- EUDAMED 700f4a31-7784-47a8-9a8d-274f87b4dba4 61 fields · synced Aug 2, 2026
- EUDAMED 4de3920c-c80b-4388-a9cb-4503583a0d98 61 fields · synced Aug 2, 2026