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RU Sleeping RTS, Intl
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1048540Model RUSleeping RTS
Identity
- Trade Name
- RU Sleeping RTS, Intl EUDAMEDRUSleeping RTS FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- RUSleeping RTS, International FDA UDI
- Model / Reference
- RUSleeping RTS EUDAMED1048540 EUDAMEDRUSleeping RTS, International FDA UDI
- Description
- RUSleeping RTS, International FDA UDI
Identifiers
- Catalog Number
- 1048540 FDA UDI
- Primary DI / UDI-DI
- 00606959020566 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959020566 EUDAMED
- 510(k) Number
- K022294 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
RU Sleeping RTS, 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-00606959020566 | 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 15d1927e-c7cf-4623-abec-7e6d8ccadc8c 61 fields · synced Jun 18, 2026
- FDA UDI 8469e2d4-05cc-4dca-bd54-5d1892031601 37 fields · synced May 30, 2026
- EUDAMED 9af716cd-2a88-4878-a5e1-ad49cf576f3f 61 fields · synced Jun 18, 2026