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Sign in to claim this brandHeidelberg Medical Inc
US
Last updated May 24, 2026
What Heidelberg Medical Inc makes
Heidelberg Medical Inc manufactures gastrointestinal telemetric monitoring systems, including ingestible capsule devices designed for pH monitoring within the digestive tract. The portfolio also includes application software for data processing, receivers to capture transmitted signals, and transceivers for wireless communication. Additional components like utility trolleys for system support are part of the offering.
These devices are classified as Class I under regulatory frameworks, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable domestic regulatory requirements for gastrointestinal monitoring systems.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Heidelberg Medical Inc manufacture?
Heidelberg Medical Inc specializes in gastrointestinal telemetric monitoring systems. This includes ingestible capsule devices like the Heidelberg pH Capsule System, which monitor pH levels in the digestive tract. Their portfolio also covers application software for analyzing data, receivers to capture signals from the capsules, transceivers for wireless communication, and utility trolleys to support system operations.
Where is Heidelberg Medical Inc based?
Heidelberg Medical Inc is based in the United States. The company operates from there while developing and manufacturing its gastrointestinal telemetric monitoring systems, adhering to applicable U.S. regulatory standards.
Which regulatory registries list Heidelberg Medical Inc’s devices?
Heidelberg Medical Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and identification of their gastrointestinal telemetric monitoring systems, including capsules, receivers, and software, under the U.S. regulatory framework.
How are Heidelberg Medical Inc’s devices classified under regulatory standards?
Heidelberg Medical Inc’s gastrointestinal telemetric monitoring systems are classified as Class I devices. This classification is typically assigned to low-risk medical devices, though individual devices must still meet regulatory requirements for safety and performance before authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- etcmail.com
- —
- —
- [email protected]
- Phone
- 800-241-7517
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 023287700
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Heidelberg pH Capsule System | Heidelberg Interface Module | FDA UDI | Class I | Active |
| Heidelberg pH Capsule System | Heidelberg pH Capsule Calibration Kit | FDA UDI | Class I | Active |
| Heidelberg pH Capsule System | Heidelberg pH Telemetric Capsules | FDA UDI | Class I | Active |
| Heidelberg pH Capsule System | Heidelberg Medallion Transceiver | FDA UDI | Class I | Active |
| Heidelberg pH Capsule System | Heidelberg pH Capsule System Software | FDA UDI | Class I | Active |
| Heidelberg pH Capsule System | Heidelberg pH Capsule System | FDA UDI | Class I | Active |
| Heidelberg pH Capsule System | Heidelberg System Equipment Cart | FDA UDI | Class I | Active |
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