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BiPAP autoSV ADV SYS ONE 60 Series, INTL
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IN961SModel BiPAP autoSV Advanced System One
Identity
- Trade Name
- BiPAP autoSV ADV SYS ONE 60 Series, INTL EUDAMEDBiPAP autoSV Advanced System One 60 Series FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- BiPAP autoSV Advanced System One 60 Series, International FDA UDI
- Model / Reference
- BiPAP autoSV Advanced System One EUDAMEDIN961S EUDAMEDBiPAP autoSV Advanced, 60 Series, INTL FDA UDI
- Description
- BiPAP autoSV Advanced System One 60 Series, International FDA UDI
Identifiers
- Catalog Number
- IN961S FDA UDI
- Primary DI / UDI-DI
- 00606959029620 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959029620 EUDAMED
- FDA Product Code
- MNS FDA UDI
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BiPAP autoSV ADV SYS ONE 60 Series, INTL by Respironics, Inc. — Class IIb — 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-00606959029620 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 (2)
- EUDAMED 51919259-2382-4a3b-9044-b5b097085836 61 fields · synced Jun 18, 2026
- FDA UDI 03d86d6b-7e58-4e03-86ca-cbca7520f043 36 fields · synced May 30, 2026