Identity
- Trade Name
- Micro-Flexible Heated 12mm Tube EUDAMEDDreamStation FDA UDI
- Generic Name
- Home BPAP unit FDA UDI
- Device Name
- DreamStation 2 EUDAMEDMicro-Flexible Heated 12mm Tube FDA UDI
- Model / Reference
- HT12 EUDAMEDMicro-Flexible Heated 12mm Tube FDA UDI
- Description
- Micro-Flexible Heated 12mm Tube FDA UDI
Identifiers
- Catalog Number
- HT12 FDA UDI
- Primary DI / UDI-DI
- 00606959417540 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959417540 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- Z12030102,Z1203010502 EUDAMED
- GMDN Term
- Home BPAP unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Micro-Flexible Heated 12mm Tube by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959417540 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 de21f6fa-bd86-4f0d-a4ec-b06e8c357c76 61 fields · synced Jun 18, 2026
- FDA UDI 304cb7e7-318b-4a60-94f0-e5e7b5b0d49b 35 fields · synced May 30, 2026