Identity
- Trade Name
- DreamStation Wifi Accesory, KR EUDAMEDDreamStation FDA UDI
- Generic Name
- Clinical laboratory information system FDA UDI
- Device Name
- DreamStation Cell, Wi-Fi, and Link EUDAMEDDreamStation WiFi Accessory, South Korea FDA UDI
- Model / Reference
- 100775W EUDAMED00 FDA UDI
- Description
- DreamStation WiFi Accessory, South Korea FDA UDI
Identifiers
- Catalog Number
- 100775W FDA UDI
- Primary DI / UDI-DI
- 00606959058187 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM218LZ EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Clinical laboratory information system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
DreamStation Wifi Accesory, KR by Respironics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0606959BM218LZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 c7d01d0d-ddac-4ae5-8b69-2f9ee3b8a3a9 61 fields · synced Jun 17, 2026
- FDA UDI 1145a399-e80a-463a-bba6-c5666290c9ab 35 fields · synced May 30, 2026