Identity
- Trade Name
- Opal DataHub FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- The Opal DataHub is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server where the files are processed. Additionally, the Opal DataHub recharges the battery of the Opal V2C sensors. FDA UDI
- Model / Reference
- V2C FDA UDI
- Description
- The Opal DataHub is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server where the files are processed. Additionally, the Opal DataHub recharges the battery of the Opal V2C sensors. FDA UDI
Identifiers
- Catalog Number
- ODHV2C FDA UDI
- Primary DI / UDI-DI
- 00850023837042 FDA UDI
- FDA Product Code
- ISD FDA UDI
- GMDN Term
- Kinesiology ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Kinesiology ambulatory recorder
Opal DataHub by eResearchTechnology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Kinesiology ambulatory recorder.
- BioStamp nPoint™ — Medidata Solutions, Inc. · Class II
- Opal V2C — APDM, INC. · Class II
- BioStamp® nPoint — Medidata Solutions, Inc. · Class II
- DataLOG Management Software (Version 10) — BIOMETRICS LIMITED · Class II
- BioStamp nPoint™ — Medidata Solutions, Inc. · Class II
- BioStamp nPoint™ — Medidata Solutions, Inc. · Class II
- BioStamp® — Medidata Solutions, Inc. · Class II
- DONJOY — DJO, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- eResearchTechnology, Inc.
Sources (1)
- FDA UDI a5c0523b-b500-48a9-9a16-004dca1340c0 36 fields · synced May 30, 2026