Identity
- Trade Name
- Actiwatch 2 Device EUDAMEDActiwatch 2 FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- Actiwatch 2 and Actiwatch Spectrum EUDAMEDActiwatch 2 Device FDA UDI
- Model / Reference
- 1048090 EUDAMEDActiwatch 2 Device FDA UDI
- Description
- Actiwatch 2 Device FDA UDI
Identifiers
- Catalog Number
- 1048090 FDA UDI
- Primary DI / UDI-DI
- 00606959003897 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959003897 EUDAMED
- FDA Product Code
- GWQ FDA UDI
- EMDN Code
- Z12062599 KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER EUDAMED
- GMDN Term
- Kinesiology ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1400 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
Actiwatch 2 Device 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-00606959003897 | 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 (2)
- EUDAMED c40bcc92-2f51-47e3-b8fa-c5248d9be435 61 fields · synced Jun 18, 2026
- FDA UDI f23f3261-f124-47cf-8600-bc51551735e6 36 fields · synced May 30, 2026