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REMstar Auto A-Flex, System One 60 Series, GB
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GB561S
Identity
- Trade Name
- REMstar Auto A-Flex, System One 60 Series, GB EUDAMEDREMstar System One 60 Series FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- REMstar System (60 Series) EUDAMEDREMstar Auto A-Flex, System One 60 Series, GB FDA UDI
- Model / Reference
- GB561S EUDAMEDREMstar Auto A-Flex, System One 60 Series, GB FDA UDI
- Description
- REMstar Auto A-Flex, System One 60 Series, GB FDA UDI
Identifiers
- Catalog Number
- GB561S FDA UDI
- Primary DI / UDI-DI
- 00606959069459 EUDAMED00606959030589 FDA UDI
- Basic UDI-DI
- B-00606959069459 EUDAMED
- 510(k) Number
- K113068 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
- 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 Auto A-Flex, System One 60 Series, GB 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-00606959069459 | 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 19a05204-f3d0-481b-aa60-3071637da0a1 61 fields · synced Jul 18, 2026
- FDA UDI 0150e9ae-bb83-4794-a086-c3299b3d76fa 37 fields · synced May 30, 2026
- EUDAMED 78be295c-dbab-48fa-a550-024389e3a42f 61 fields · synced Jul 18, 2026