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REMstar SE with HUMIDIFIER, with SD Slot, INTL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IN221HS
Identity
- Trade Name
- REMstar SE with HUMIDIFIER, with SD Slot, INTL EUDAMEDREMstar SE FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- REMstar, REMstar SE, Dorma EUDAMEDREMstar SE with Humidifier, with SD Slot, International FDA UDI
- Model / Reference
- IN221HS EUDAMEDREMstar SE with HUMIDIFIER, with SD Slot, INTL FDA UDI
- Description
- REMstar SE with Humidifier, with SD Slot, International FDA UDI
Identifiers
- Catalog Number
- IN221HS FDA UDI
- Primary DI / UDI-DI
- 00606959036918 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959036918 EUDAMED
- 510(k) Number
- K130077 FDA UDI
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- Z1203010502 ADULT PULMONARY VENTILATORS 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
REMstar SE with HUMIDIFIER, with SD Slot, INTL 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-00606959036918 | 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 25ece23a-88cd-4649-9798-a8a89da0938d 61 fields · synced Jul 26, 2026
- FDA UDI da07d4dc-3564-4410-9ef8-5e7742488472 37 fields · synced May 30, 2026
- EUDAMED f54c2297-ca5d-4c62-891e-c734db5a3a76 61 fields · synced Jul 26, 2026