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BiPAP Auto BiFlex, System One, 60 Series, IT
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IT761SModel BiPAP Auto Bi-Flex
Identity
- Trade Name
- BiPAP Auto BiFlex, System One, 60 Series, IT EUDAMEDBiPAP Auto BiFlex FDA UDI
- Generic Name
- Home BPAP unit FDA UDI
- Device Name
- BiPAP Auto BiFlex, System One 60 Series, italy FDA UDI
- Model / Reference
- BiPAP Auto Bi-Flex EUDAMEDIT761S EUDAMEDBiPAP Auto BiFlex, System One 60 Series, Italy FDA UDI
- Description
- BiPAP Auto BiFlex, System One 60 Series, italy FDA UDI
Identifiers
- Catalog Number
- IT761S FDA UDI
- Primary DI / UDI-DI
- 00606959048256 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959048256 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
- GMDN Term
- Home BPAP unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BiPAP Auto BiFlex, System One, 60 Series, IT by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959048256 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 9fa21027-2099-402a-b204-84dc55027967 61 fields · synced Jul 10, 2026
- FDA UDI 6493f3db-81a6-43b7-b60c-c3e07a766825 36 fields · synced May 29, 2026
- EUDAMED 31a33939-9a59-4f6e-a714-cdede2e55cd9 61 fields · synced Jul 10, 2026