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Actiwatch Spectrum Device Recertified
EUDAMEDClass IIa (EU MDR)
Ref U1048091Model Actiwatch 2 and Actiwatch Spectrum
Identity
- Trade Name
- Actiwatch Spectrum Device Recertified EUDAMED
- Model / Reference
- Actiwatch 2 and Actiwatch Spectrum EUDAMEDU1048091 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00606959409798 EUDAMED
- Basic UDI-DI
- B-00606959409798 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 Device 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-00606959409798 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (1)
- EUDAMED 325c0abf-b32a-4e89-90e0-61d2a67e078a 61 fields · synced Jun 17, 2026