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FitMax® CPAP Total Face Mask with Standard Elbow and Corrugate Tube, Size: XS
EUDAMEDClass IIa (EU MDR)
Ref CA-63603
Identity
- Trade Name
- FitMax® CPAP Total Face Mask with Standard Elbow and Corrugate Tube, Size: XS EUDAMED
- Device Name
- FitMax® CPAP Total Face Mask with Standard Elbow and Corrugate Tube, Size: XS EUDAMED
- Model / Reference
- CA-63603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04716770636030 EUDAMED
- Basic UDI-DI
- 4716770CA0630179 EUDAMED
- Direct Marketing DI
- 04716770636030 EUDAMED
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
FitMax® CPAP Total Face Mask with Standard Elbow and Corrugate Tube, Size: XS by Besmed Health Business Corp. — Class IIa — MDR — listed in EUDAMED
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 | 4716770CA0630179 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
- EUDAMED SRN
- TW-MF-000007246
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED 11bd98cf-f98d-467a-b2e7-c535aefe5573 61 fields · synced Jun 18, 2026