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REMstar Pro C-Flex+, with Humidifier, 60 Series, INTL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IN461HS
Identity
- Trade Name
- REMstar Pro C-Flex+, with Humidifier, 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+, with Humidifier, System One 60 Series, International FDA UDI
- Model / Reference
- IN461HS EUDAMEDREMstar Pro C-Flex+, with Humidifier, 60 Series, INTL FDA UDI
- Description
- REMstar Pro C-Flex+, with Humidifier, System One 60 Series, International FDA UDI
Identifiers
- Catalog Number
- IN461HS FDA UDI
- Primary DI / UDI-DI
- 00606959069305 EUDAMED00606959030268 FDA UDI
- Basic UDI-DI
- B-00606959069305 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
- Denmark EUDAMED
- Commercial Distribution
- Not 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+, with Humidifier, 60 Series, INTL by Respironics Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00606959069305 | 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 6996ba10-988a-420b-94d7-77b8686b024d 61 fields · synced Jul 20, 2026
- FDA UDI e5d23fa2-2614-4857-91b9-da5eaf8c8faf 37 fields · synced May 30, 2026
- EUDAMED d8acfe0a-ecb4-4e8f-bd28-217347be5b98 61 fields · synced Jul 20, 2026