Identity
- Trade Name
- Actiwatch Spectrum PRO EUDAMEDActiwatch FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- Actiwatch Spectrum Pro and Actiwatch Spe EUDAMEDActiwatch Spectrum Pro FDA UDI
- Model / Reference
- 1099351 EUDAMEDActiwatch Spectrum Pro FDA UDI
- Description
- Actiwatch Spectrum Pro FDA UDI
Identifiers
- Catalog Number
- 1099351 FDA UDI
- Primary DI / UDI-DI
- 00606959021402 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959021402 EUDAMED
- FDA Product Code
- IKK FDA UDI
- EMDN Code
- Z12040117 METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS EUDAMED
- GMDN Term
- Kinesiology ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Actiwatch Spectrum PRO by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959021402 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED ff9c6f0e-97ed-49fd-af5b-ebc0372677b9 61 fields · synced Jun 19, 2026
- FDA UDI 2005aa1d-06c4-453b-bcd5-bba8e634ac49 36 fields · synced May 30, 2026
- EUDAMED 4740f470-d9f8-4ae4-b7f4-a9a026f65c69 61 fields · synced Jun 19, 2026