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ActiWatch Spectrum System
EUDAMEDClass IIa (EU MDR)
Ref 1046964Model Actiwatch 2 and Actiwatch Spectrum
Identity
- Trade Name
- ActiWatch Spectrum System EUDAMED
- Model / Reference
- Actiwatch 2 and Actiwatch Spectrum EUDAMED1046964 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959020511 EUDAMED
- Basic UDI-DI
- B-00606959020511 EUDAMED
- EMDN Code
- Z12062599 KINEMATIC MOTION CAPTURE ANALYSIS SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ActiWatch Spectrum System by Respironics, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959020511 | Class IIa | Active |
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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 953a0cca-e502-4bd0-8374-f24a80b6b5c8 61 fields · synced Jun 19, 2026
- EUDAMED 10420e6c-f517-4608-8bf1-784eeca6d733 61 fields · synced Jun 19, 2026