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Actiwatch Spectrum Communication Dock System
EUDAMEDClass IIa (EU MDR)
Ref 1048093Model Actiwatch 2 and Actiwatch Spectrum
Identity
- Trade Name
- Actiwatch Spectrum Communication Dock System EUDAMED
- Model / Reference
- Actiwatch 2 and Actiwatch Spectrum EUDAMED1048093 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959020542 EUDAMED
- Basic UDI-DI
- B-00606959020542 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 Communication Dock 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-00606959020542 | 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 (1)
- EUDAMED 82377ba4-ea55-41c8-a7fa-3e6c6e7f7c5c 61 fields · synced Jun 17, 2026