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Actiware Software Web Download - 6
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1104776
Identity
- Trade Name
- Actiware Software Web Download - 6 EUDAMEDAcitware FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- Actiware Software, Actiware CT Software EUDAMEDActiware Activity Analysis Software (for use with Actiwatch Activity Trackers) FDA UDI
- Model / Reference
- 1104776 EUDAMEDActiware Software Web Download - 6 FDA UDI
- Description
- Actiware Activity Analysis Software (for use with Actiwatch Activity Trackers) FDA UDI
Identifiers
- Catalog Number
- 1104776 FDA UDI
- Primary DI / UDI-DI
- 00606959039872 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959039872 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 Software Web Download - 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-00606959039872 | 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 01a98a12-a896-4d28-805a-1f54a910172f 61 fields · synced Jun 19, 2026
- FDA UDI e33b715d-0f3c-4220-b694-355bddead5c3 35 fields · synced May 30, 2026
- EUDAMED 3c6f7824-8147-4613-8fb4-e2e98f9376ec 61 fields · synced Jun 19, 2026