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BiPAP autoSV ADV SYS ONE w/Humid, 60 Series INTL
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IN961HSModel BiPAP autoSV Advanced System One
Identity
- Trade Name
- BiPAP autoSV ADV SYS ONE w/Humid, 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 with Humidifier, International FDA UDI
- Model / Reference
- BiPAP autoSV Advanced System One EUDAMEDIN961HS EUDAMEDBiPAP autoSV Advanced w/ Humidifier, 60 Series, INTL FDA UDI
- Description
- BiPAP autoSV Advanced System One 60 Series with Humidifier, International FDA UDI
Identifiers
- Catalog Number
- IN961HS FDA UDI
- Primary DI / UDI-DI
- 00606959029637 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959029637 EUDAMED
- FDA Product Code
- BZD FDA UDIMNS 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
- 868.5905 FDA UDI868.5895 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 w/Humid, 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-00606959029637 | 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 (3)
- EUDAMED 96870ddb-4ed3-4855-8f8e-cc2ef99073a4 61 fields · synced Jun 18, 2026
- FDA UDI 8f42c14b-3d66-42d7-964e-2406c7ce88cf 36 fields · synced May 29, 2026
- EUDAMED 4e1f66cc-7f1a-448a-a539-64ac37202e33 61 fields · synced Jun 11, 2026