Identity
- Trade Name
- Rental-DreamStation Cellular Modem, EU EUDAMED
- Device Name
- DreamStation Cell, Wi-Fi, and Link EUDAMED
- Model / Reference
- R100621C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959416673 EUDAMED
- Basic UDI-DI
- 0606959BM218LZ EUDAMED
- Direct Marketing DI
- 00606959416673 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
Rental-DreamStation Cellular Modem, EU 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 (1)
- EUDAMED 582cec50-bad5-4d70-b4bc-99b4f8719cae 61 fields · synced Jun 17, 2026