Identity
- Trade Name
- AW CT Regeneron R3500-AD-1798 Pkg Scorer EUDAMED
- Device Name
- Actiware Software, Actiware CT Software EUDAMED
- Model / Reference
- 1140958 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959418998 EUDAMED
- Basic UDI-DI
- B-00606959418998 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 Regeneron R3500-AD-1798 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-00606959418998 | 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 10fb5d4c-d4cb-4d05-ba9e-e46619c567cb 61 fields · synced Jul 20, 2026
- EUDAMED c3ec6088-6a10-48eb-a716-fdfa75e46047 61 fields · synced Jul 20, 2026