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Sign in to claim this brandTYROLMED GmbH
US
Last updated May 24, 2026
What TYROLMED GmbH makes
TYROLMED GmbH manufactures single-use electrocardiographic electrodes, designed for temporary attachment to the skin to record heart activity during diagnostic procedures. These electrodes are intended for use in electrocardiogram (ECG) monitoring and related cardiac assessments.
The company’s products fall under Class II regulatory classification in the US and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
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 TYROLMED GmbH manufacture?
TYROLMED GmbH specializes in single-use electrocardiographic electrodes. These electrodes are designed for temporary skin attachment to capture heart activity during ECG monitoring and cardiac assessments. The focus is on disposable, reusable diagnostic tools for heart-related procedures.
Where is TYROLMED GmbH based?
TYROLMED GmbH is based in the United States. The company’s location is relevant for understanding its regulatory framework and market focus, particularly in the US healthcare system.
How are TYROLMED GmbH’s devices classified in the US?
TYROLMED GmbH’s electrocardiographic electrodes are classified as Class II devices in the US. This classification indicates a moderate level of risk, requiring compliance with specific regulatory controls to ensure safety and effectiveness before market authorization.
Are TYROLMED GmbH’s devices listed in any regulatory registries?
Yes, TYROLMED GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the US market, ensuring transparency and traceability for healthcare providers and regulators.
Why are TYROLMED GmbH’s electrodes considered single-use?
TYROLMED GmbH’s electrodes are designed as single-use to minimize infection risks, ensure consistent performance, and maintain hygiene standards in clinical settings. Single-use devices are typically discarded after one procedure, reducing cross-contamination and improving patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 300387502
Catalogue (93)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Swaromed | 1083 | FDA UDI | Class II | Active |
| Swaromed | 4113 | FDA UDI | Class II | Active |
| Swaromed | 1084 | FDA UDI | Class II | Active |
| Swaromed | 1009 | FDA UDI | Class II | Active |
| Swaromed | 1085 | FDA UDI | Class II | Active |
| Swaromed | 1043 | FDA UDI | Class II | Active |
| Swaromed | 4102 | FDA UDI | Class II | Active |
| Swaromed | 4077 | FDA UDI | Class II | Active |
| Swaromed | 1033 | FDA UDI | Class II | Active |
| Swaromed | 4101 | FDA UDI | Class II | Active |
| Swaromed | 1032 | FDA UDI | Class II | Active |
| Swaromed | 4701 | FDA UDI | Class II | Active |
| Swaromed | 4704 | FDA UDI | Class II | Active |
| Swaromed | 1058D | FDA UDI | Class II | Active |
| Swaromed | 1022 | FDA UDI | Class II | Active |
| Swaromed | 4050 | FDA UDI | Class II | Active |
| Swaromed | 4002 | FDA UDI | Class II | Active |
| Swaromed | 1023 | FDA UDI | Class II | Active |
| Swaromed | 4702 | FDA UDI | Class II | Active |
| Swaromed | 1057 | FDA UDI | Class II | Active |
| Swaromed | 1019 | FDA UDI | Class II | Active |
| Swaromed | 4040 | FDA UDI | Class II | Active |
| Swaromed | 1032 | FDA UDI | Class II | Active |
| Swaromed | 4109 | FDA UDI | Class II | Active |
| Swaromed | 1036FT | FDA UDI | Class II | Active |
| Swaromed | 4008D | FDA UDI | Class II | Active |
| Swaromed | 1042 | FDA UDI | Class II | Active |
| Swaromed | 1036 | FDA UDI | Class II | Active |
| Swaromed | 1035 | FDA UDI | Class II | Active |
| Swaromed | 4051 | FDA UDI | Class II | Active |
| Swaromed | 1033 | FDA UDI | Class II | Active |
| Swaromed | 1036E | FDA UDI | Class II | Active |
| Swaromed | 1060 | FDA UDI | Class II | Active |
| Swaromed | 4112 | FDA UDI | Class II | Active |
| Swaromed | 4008D | FDA UDI | Class II | Active |
| Swaromed | 1057 | FDA UDI | Class II | Active |
| Swaromed | 4009 | FDA UDI | Class II | Active |
| Swaromed | 4114 | FDA UDI | Class II | Active |
| Swaromed | 1001 | FDA UDI | Class II | Active |
| Swaromed | 1055 | FDA UDI | Class II | Active |
| Swaromed | 4010 | FDA UDI | Class II | Active |
| Swaromed | 4057 | FDA UDI | Class II | Active |
| Swaromed | 1008D | FDA UDI | Class II | Active |
| Swaromed | 1037D | FDA UDI | Class II | Active |
| Swaromed | 4008D | FDA UDI | Class II | Active |
| Swaromed | 4023 | FDA UDI | Class II | Active |
| Swaromed | 1010 | FDA UDI | Class II | Active |
| Swaromed | 1009 | FDA UDI | Class II | Active |
| Swaromed | 4106 | FDA UDI | Class II | Active |
| Swaromed | 1039 | FDA UDI | Class II | Active |
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