← Back to catalogue
BiPAP Pro BiFlex System One 60 Series INT
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IN661S
Identity
- Trade Name
- BiPAP Pro BiFlex System One 60 Series INT EUDAMEDBiPAP System One 60 Series FDA UDI
- Generic Name
- Home BPAP unit FDA UDI
- Device Name
- REMstar System (60 Series) EUDAMEDBiPAP Pro BiFlex, System One 60 Series, International FDA UDI
- Model / Reference
- IN661S EUDAMEDBiPAP Pro BiFlex System One 60 Series INT FDA UDI
- Description
- BiPAP Pro BiFlex, System One 60 Series, International FDA UDI
Identifiers
- Catalog Number
- IN661S FDA UDI
- Primary DI / UDI-DI
- 00606959069343 EUDAMED00606959031197 FDA UDI
- Basic UDI-DI
- B-00606959069343 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
- Denmark 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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 Pro BiFlex System One 60 Series INT 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-00606959069343 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (3)
- EUDAMED fc0f3e64-1bfc-4aec-a6e0-c97f7865c85b 61 fields · synced Jul 10, 2026
- FDA UDI 6e118a31-4874-4b3c-b805-7b2ba5321c77 36 fields · synced May 30, 2026
- EUDAMED 54e828d6-50ac-46d9-8530-c3e2804639d7 61 fields · synced Jul 10, 2026