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REMstar Pro C-Flex+, 60 Series, INTL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IN461S
Identity
- Trade Name
- REMstar Pro C-Flex+, 60 Series, INTL EUDAMEDREMstar System One 60 Series FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- REMstar System (60 Series) EUDAMEDREMstar Pro C-Flex+, System One 60 Series, International FDA UDI
- Model / Reference
- IN461S EUDAMEDREMstar Pro C-Flex+, 60 Series, INTL FDA UDI
- Description
- REMstar Pro C-Flex+, System One 60 Series, International FDA UDI
Identifiers
- Catalog Number
- IN461S FDA UDI
- Primary DI / UDI-DI
- 00606959069299 EUDAMED00606959030251 FDA UDI
- Basic UDI-DI
- B-00606959069299 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
- GMDN Term
- Home CPAP unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 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
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
REMstar Pro C-Flex+, 60 Series, INTL 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-00606959069299 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 1dfc64ee-be82-49e4-9583-c6f82441be37 61 fields · synced Jul 29, 2026
- FDA UDI 2af9d56e-193d-4efc-9c13-f591a0010d20 36 fields · synced May 30, 2026
- EUDAMED 33f0136b-fade-41e1-91da-92fc67b5981a 61 fields · synced Jul 29, 2026