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DreamStation Micro-Flex PR12 Tube Starter Pack
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1128071
Identity
- Trade Name
- DreamStation Micro-Flex PR12 Tube Starter Pack EUDAMEDDreamStation FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- DreamStation EUDAMEDDreamStation Micro-Flex PR12 Tube Starter Pack FDA UDI
- Model / Reference
- 1128071 EUDAMEDDreamStation Micro-Flex PR12 Tube Starter Pack FDA UDI
- Description
- DreamStation Micro-Flex PR12 Tube Starter Pack FDA UDI
Identifiers
- Catalog Number
- 1128071 FDA UDI
- Primary DI / UDI-DI
- 00606959040502 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959040502 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- Z12030102,Z1203010502 EUDAMED
- GMDN Term
- Home CPAP 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
DreamStation Micro-Flex PR12 Tube Starter Pack 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-00606959040502 | 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 (3)
- EUDAMED e45afc1b-347e-4d89-a800-78ffa5d777c2 61 fields · synced Jul 30, 2026
- FDA UDI e9801edc-1c14-42a1-950e-cf16072edc1f 36 fields · synced May 29, 2026
- EUDAMED d10133b3-40e7-48ef-87c9-1c20b223b39c 61 fields · synced Jul 30, 2026