Identity
- Trade Name
- Actiwatch Spectrum Plus-Recertified EUDAMED
- Device Name
- Actiwatch Spectrum Pro and Actiwatch Spe EUDAMED
- Model / Reference
- U1101894 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959409842 EUDAMED
- Basic UDI-DI
- B-00606959409842 EUDAMED
- EMDN Code
- Z12040117 METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS 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
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
Actiwatch Spectrum Plus-Recertified 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-00606959409842 | 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 ab00a794-f6a6-41cf-ad44-920d672527ba 61 fields · synced Jun 17, 2026