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BiPAP autoSV ADV SYS ONE w/Humid, 60 Series, GER
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref DE962HSModel BiPAP autoSV Advanced System One
Identity
- Trade Name
- BiPAP autoSV ADV SYS ONE w/Humid, 60 Series, GER 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, Germany FDA UDI
- Model / Reference
- BiPAP autoSV Advanced System One EUDAMEDDE962HS EUDAMEDBiPAP autoSV Advanced, with Humidifier, 60 Series, DE FDA UDI
- Description
- BiPAP autoSV Advanced System One 60 Series with Humidifier, Germany FDA UDI
Identifiers
- Catalog Number
- DE962HS FDA UDI
- Primary DI / UDI-DI
- 00606959029699 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959029699 EUDAMED
- FDA Product Code
- MNS FDA UDIBZD 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 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
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, GER 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-00606959029699 | 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 10b33624-1d47-415e-828c-aea26d871c3d 61 fields · synced Jun 19, 2026
- FDA UDI cf021f02-bbf4-4ebf-b98f-8831c2919c2a 36 fields · synced May 30, 2026
- EUDAMED 4867bf94-a6e1-44f0-b729-aeed10a58712 61 fields · synced Jun 19, 2026