← Back to catalogue
Web, DirectView Software
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1055635Model DirectView PC Software Application
Identity
- Trade Name
- Web, DirectView Software EUDAMEDDirectView FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- DirectView Software Version 2.4 FDA UDI
- Model / Reference
- DirectView PC Software Application EUDAMED1055635 EUDAMEDDirectView PC Software Application, Web - 2 FDA UDI
- Description
- DirectView Software Version 2.4 FDA UDI
Identifiers
- Catalog Number
- 1063558 FDA UDI
- Primary DI / UDI-DI
- 00606959028630 EUDAMEDFDA UDI
- Basic UDI-DI
- 0606959BM132LN EUDAMED
- Direct Marketing DI
- 00606959028630 EUDAMED
- FDA Product Code
- MNS FDA UDICBK FDA UDINHJ FDA UDIMNT FDA UDI
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS EUDAMED
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI868.5905 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
Web, DirectView Software by Respironics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0606959BM132LN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 092b5010-96cc-43b7-ae44-291572adff90 61 fields · synced Jun 18, 2026
- FDA UDI 4ba4fa64-18c9-44d0-9b49-f49ea1830d82 35 fields · synced May 30, 2026
- EUDAMED 96d6ad33-7ee9-4efd-b0cb-bb88ce9b1a35 61 fields · synced Jun 18, 2026