Identity
- Trade Name
- AW CT TAK-994-1503 Site EUDAMED
- Device Name
- Actiware Software, Actiware CT Software EUDAMED
- Model / Reference
- 1148461 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959423091 EUDAMED
- Basic UDI-DI
- B-00606959423091 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 TAK-994-1503 Site 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-00606959423091 | 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 73a1b7a1-dc23-45f4-b97a-9c43a74a09b9 61 fields · synced Jun 19, 2026
- EUDAMED a0986e50-d946-48ef-b208-877f2dfa7c23 61 fields · synced Jun 19, 2026