← Back to catalogue
BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, GER
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref DE962TSModel BiPAP autoSV Advanced System OneRef IN961TS
Identity
- Trade Name
- BiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, GER EUDAMEDBiPAP autoSV ADV SYS ONE w/HT Humid, 60 Series, INT 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 Heated Tube Humidifier, International FDA UDIBiPAP autoSV Advanced System One 60 Series with Heated Tube Humidiifer, Germany FDA UDI
- Model / Reference
- BiPAP autoSV Advanced System One EUDAMEDDE962TS EUDAMEDIN961TS EUDAMEDBiPAP autoSV Advanced w/H Tube Humid, 60 Series, INTL FDA UDIBiPAP autoSV Advanced w/H Tube Humid, 60 Series, DE FDA UDI
- Description
- BiPAP autoSV Advanced System One 60 Series with Heated Tube Humidifier, International FDA UDIBiPAP autoSV Advanced System One 60 Series with Heated Tube Humidiifer, Germany FDA UDI
Identifiers
- Catalog Number
- IN961TS FDA UDIDE962TS FDA UDI
- Primary DI / UDI-DI
- 00606959029705 EUDAMEDFDA UDI00606959029644 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959029705 EUDAMEDB-00606959029644 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/HT 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-00606959029705 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (6)
- EUDAMED b6f28c2a-e590-4289-b2d7-70a93a0b4ff9 61 fields · synced Oct 7, 2026
- EUDAMED 7fa4aa35-1984-46b1-bb69-533419fb6a6d 61 fields · synced May 19, 2026
- FDA UDI f102d458-7061-4de1-8ff6-921c8ea4c149 36 fields · synced May 30, 2026
- FDA UDI d9bb0c91-a794-468a-a1ea-b75b3b739312 36 fields · synced May 30, 2026
- EUDAMED 78427734-6d55-4238-926d-84e377595641 61 fields · synced Jun 19, 2026
- EUDAMED c1e3872e-2672-4eba-a976-b36c23bfbf1a 61 fields · synced Jul 9, 2026