Identity
- Trade Name
- DreamStation Cell, Dipole, EU, Rental EUDAMEDDreamStation Cellular Modem, Dipole, EU Rental EUDAMED
- Device Name
- DreamStation Cell, Wi-Fi, and Link EUDAMED
- Model / Reference
- R100625C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959420359 EUDAMED
- Basic UDI-DI
- 0606959BM218LZ EUDAMED
- Direct Marketing DI
- 00606959420359 EUDAMED
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
DreamStation Cell, Dipole, EU, Rental by Respironics, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0606959BM218LZ | Class I | Active |
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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 eebab7fb-c7b2-4cb7-ba7d-746d111ad71d 61 fields · synced Aug 1, 2026
- EUDAMED f06cd2ae-be01-4662-9e5b-53811c4d19ba 61 fields · synced Aug 1, 2026