Identity
- Trade Name
- AW CT Kiniksa KPL-OBS001 Pkg Scorer EUDAMED
- Device Name
- Actiware Software, Actiware CT Software EUDAMED
- Model / Reference
- 1135139 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959415973 EUDAMED
- Basic UDI-DI
- B-00606959415973 EUDAMED
- EMDN Code
- Z12040117 METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
AW CT Kiniksa KPL-OBS001 Pkg Scorer 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-00606959415973 | 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 d488b0f8-5b52-4555-a4d7-28d3bcbb4bfc 61 fields · synced Jul 10, 2026
- EUDAMED 5e60a8b2-07fd-4f19-96e0-2fe6bfc6d0f7 61 fields · synced Jul 10, 2026