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Actiware Clinical Trial Software, English - 6
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1103609
Identity
- Trade Name
- Actiware Clinical Trial Software, English - 6 EUDAMEDActiware FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- Actiware Software, Actiware CT Software EUDAMEDActiware Clinical Trial Software, English FDA UDI
- Model / Reference
- 1103609 EUDAMEDActiware Clinical Trial Software, English - 6 FDA UDI
- Description
- Actiware Clinical Trial Software, English FDA UDI
Identifiers
- Catalog Number
- 1103609 FDA UDI
- Primary DI / UDI-DI
- 00606959040366 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959040366 EUDAMED
- FDA Product Code
- IKK FDA UDI
- EMDN Code
- Z12040117 METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS EUDAMED
- GMDN Term
- Kinesiology ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Special Device Type
- -1192 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Actiware Clinical Trial Software, English - 6 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-00606959040366 | 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 f98e8261-42f4-4632-9514-f93f2210e837 61 fields · synced Jul 9, 2026
- FDA UDI b8289529-ebdc-4c77-b3a7-2d42744fbac3 35 fields · synced May 30, 2026
- EUDAMED df7e4609-79ab-4002-b008-7e4fe31b1118 61 fields · synced Jul 9, 2026