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Actiwatch 2 Communication Dock System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1048092
Identity
- Trade Name
- Actiwatch 2 Communication Dock System EUDAMEDActiwatch 2 FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- Actiwatch 2 and Actiwatch Spectrum EUDAMEDActiwatch 2 Communication Dock System FDA UDI
- Model / Reference
- 1048092 EUDAMEDActiwatch 2 Communication Dock System FDA UDI
- Description
- Actiwatch 2 Communication Dock System FDA UDI
Identifiers
- Catalog Number
- 1048092 FDA UDI
- Primary DI / UDI-DI
- 00606959003903 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959003903 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 Communication Dock System 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-00606959003903 | 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 c866590a-96b4-40fa-9930-af07cf68b27e 61 fields · synced Jun 19, 2026
- FDA UDI 0341ae83-2e3a-4f80-9e01-d1bb5384d2a2 36 fields · synced May 30, 2026
- EUDAMED 8454b125-d796-4a74-9628-9ae4a0b303d8 61 fields · synced Jun 19, 2026