Identity
- Trade Name
- ActiGraph LEAP EUDAMEDActiGraph FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- ActiGraph LEAP EUDAMEDThe ActiGraph LEAP™ is a small, worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiGraph LEAP™ can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. FDA UDI
- Model / Reference
- LEAP EUDAMEDFDA UDI
- Description
- The ActiGraph LEAP™ is a small, worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiGraph LEAP™ can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. FDA UDI
Identifiers
- Catalog Number
- LEAP FDA UDI
- Primary DI / UDI-DI
- 00853048008053 EUDAMEDFDA UDI
- Basic UDI-DI
- 0853048008053UU EUDAMED
- Direct Marketing DI
- 00853048008053 EUDAMED
- 510(k) Number
- K231532 FDA UDI
- FDA Product Code
- LEL FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Kinesiology ambulatory recorder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
ActiGraph LEAP by ActiGraph — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0853048008053UU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ActiGraph
- EUDAMED SRN
- US-MF-000007954
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 98cb5957-6ece-42c2-bcc3-552f39c16a7e 61 fields · synced Jul 25, 2026
- FDA UDI 623ee0e4-d2c9-4de3-afc5-4ae0f1f02232 35 fields · synced May 30, 2026