Identity
- Trade Name
- DreamStation Auto CPAP, INTL EUDAMEDDreamStation FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- DreamStation EUDAMEDDreamStation Auto CPAP, International FDA UDI
- Model / Reference
- INX500S15 EUDAMEDDreamStation Auto CPAP, INTL FDA UDI
- Description
- DreamStation Auto CPAP, International FDA UDI
Identifiers
- Catalog Number
- INX500S15 FDA UDI
- Primary DI / UDI-DI
- 00606959424739 EUDAMED00606959025875 FDA UDI
- Basic UDI-DI
- B-00606959424739 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- Z12030102,Z1203010502 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
DreamStation Auto CPAP, 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-00606959424739 | 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 e9955815-c847-442b-84f1-3ebf171b0904 61 fields · synced Jun 18, 2026
- FDA UDI ac927edc-9542-489a-adeb-75e9ecab83ff 36 fields · synced May 30, 2026