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REMstar Auto A-Flex, System One 60 Series, Germany
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DE562S
Identity
- Trade Name
- REMstar Auto A-Flex, System One 60 Series, Germany 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, Germany FDA UDI
- Model / Reference
- DE562S EUDAMEDREMstar Auto A-Flex, System One 60 Series, Germany FDA UDI
- Description
- REMstar Auto A-Flex, System One 60 Series, Germany FDA UDI
Identifiers
- Catalog Number
- DE562S FDA UDI
- Primary DI / UDI-DI
- 00606959070004 EUDAMED00606959030503 FDA UDI
- Basic UDI-DI
- B-00606959070004 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
- Germany 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 Auto A-Flex, System One 60 Series, Germany 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-00606959070004 | 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 39a99ac7-0148-4417-a967-c06644465490 61 fields · synced Jun 20, 2026
- FDA UDI c3b4a25b-a3c1-4063-b750-5dac2aeb7624 38 fields · synced May 30, 2026
- EUDAMED 72b9a404-f554-45a2-b734-e61bf2ce4117 61 fields · synced Jun 20, 2026