Identity
- Trade Name
- Mini Telemetry System FDA UDI
- Generic Name
- Cardiotocography telemetric monitoring system FDA UDI
- Model / Reference
- 2051444-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682117173 FDA UDI
- 510(k) Number
- K110556 FDA UDI
- FDA Product Code
- HGM FDA UDI
- GMDN Term
- Cardiotocography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2740 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
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: Cardiotocography telemetric monitoring system
Mini Telemetry System by Wipro GE Healthcare Private Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mini Telemetry System — Wipro GE Healthcare Private Ltd · Class II
- Mini Telemetry System — Wipro GE Healthcare Private Ltd · Class II
- Mini Telemetry System — Wipro GE Healthcare Private Ltd · Class II
Cleared under the same submission
K110556 also covers:
- Mini Telemetry System — Wipro GE Healthcare Private Ltd
- Mini Telemetry System — Wipro GE Healthcare Private Ltd
- Mini Telemetry System — Wipro GE Healthcare Private Ltd
- Mini Telemetry System — Wipro GE Healthcare Private Ltd
- Mini Telemetry System — Wipro GE Healthcare Private Ltd
- Mini Telemetry System — Wipro GE Healthcare Private Ltd
- Mini Telemetry System — Wipro GE Healthcare Private Ltd
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 |
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Manufacturer
- Manufacturer
- Wipro GE Healthcare Private Ltd
Sources (1)
- FDA UDI 1d971f09-5013-4c8d-ba7f-21ad9d822287 35 fields · synced Jun 8, 2026