Identity
- Trade Name
- DreamStation 2 CPAP Humid/BT only, IT EUDAMED
- Device Name
- DreamStation 2 EUDAMED
- Model / Reference
- ITX410H15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959063631 EUDAMED
- Basic UDI-DI
- B-00606959063631 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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 2 CPAP Humid/BT only, IT 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-00606959063631 | 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 (2)
- EUDAMED b80275ba-d0ac-45f6-a9ff-0e6e64c67a32 61 fields · synced Jul 26, 2026
- EUDAMED 0be76b21-1d53-47da-a99e-649bbc8a0791 61 fields · synced Jul 26, 2026