Identity
- Trade Name
- DreamStation Travel Kit, 65W P/S, EU EUDAMED
- Device Name
- DreamStation EUDAMED
- Model / Reference
- EU1120135 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959413665 EUDAMED
- Basic UDI-DI
- B-00606959413665 EUDAMED
- EMDN Code
- Z12030102,Z1203010502 EUDAMED
Classification
- Device Class
- Class IIa 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 Travel Kit, 65W P/S, EU by Respironics, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959413665 | Class IIa | 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 74c40852-d1d7-4f26-8b0d-27a463c5c5e9 61 fields · synced Jun 18, 2026