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REMstar Pro C-Flex+, System One 60 Series, Italy
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IT461S
Identity
- Trade Name
- REMstar Pro C-Flex+, System One 60 Series, Italy EUDAMEDREMstar FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- REMstar System (60 Series) EUDAMEDREMstar Pro C-Flex+, System One 60 Series, Italy FDA UDI
- Model / Reference
- IT461S EUDAMEDREMstar Pro C-Flex+, System One 60 Series, Italy FDA UDI
- Description
- REMstar Pro C-Flex+, System One 60 Series, Italy FDA UDI
Identifiers
- Catalog Number
- IT461S FDA UDI
- Primary DI / UDI-DI
- 00606959070035 EUDAMED00606959048218 FDA UDI
- Basic UDI-DI
- B-00606959070035 EUDAMED
- 510(k) Number
- K021861 FDA UDI
- 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
- Italy 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+, System One 60 Series, Italy 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-00606959070035 | 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 (2)
- EUDAMED 7f2117ff-2f0a-4fd0-a5c5-7c2627738259 61 fields · synced Jun 18, 2026
- FDA UDI 306a520d-fa15-4369-887d-b76d84ca8605 38 fields · synced May 29, 2026