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S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1052553Model PerforMax EE Total Face Mask
Identity
- Trade Name
- S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG EUDAMEDPerforMax FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- Performax Mask with Entrainment Elbow, Leak 2, Standard Elbow, 4 Point Headgear, Multi Patient Use, International, Small FDA UDI
- Model / Reference
- PerforMax EE Total Face Mask EUDAMED1052553 EUDAMEDPerformaxMask w/EE, Leak2, SE, 4PT Hdgr, MPU, INTL, Sm FDA UDI
- Description
- Performax Mask with Entrainment Elbow, Leak 2, Standard Elbow, 4 Point Headgear, Multi Patient Use, International, Small FDA UDI
Identifiers
- Catalog Number
- 1052553 FDA UDI
- Primary DI / UDI-DI
- 00606959008007 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959008007 EUDAMED
- FDA Product Code
- CBK FDA UDIBZD FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI868.5905 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
S PerforMax MPU INTL w/EE Leak 2 & SE, Plus 4 HG by Respironics Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103395 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00606959008007 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 99a7ceb2-61e2-4add-833e-d43cadab5ef5 61 fields · synced Oct 6, 2026
- FDA UDI dc981fb6-3ee9-478c-91bc-90eae41ded68 36 fields · synced May 30, 2026
- FDA 510(k) K103395 1 fields · synced May 25, 2026