Identity
- Trade Name
- DreamStation Accy Module EUDAMEDDreamStation Serial Accessory EUDAMED
- Device Name
- DreamStation Cell, Wi-Fi, and Link EUDAMED
- Model / Reference
- 1123881 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959412446 EUDAMED
- Basic UDI-DI
- 0606959BM218LZ 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 Accy Module 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED edafcaf2-de16-4cde-820f-7fd80a0f8512 61 fields · synced Sep 17, 2026
- EUDAMED 41cb6cb5-44cb-4064-aa36-61d397fa09e3 61 fields · synced Sep 17, 2026