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Sign in to claim this brandClearlake-Tech Inc.
United States·US-MF-000010642
Last updated May 23, 2026
What Clearlake-Tech Inc. makes
Clearlake-Tech Inc. manufactures reusable transcutaneous electrical stimulation electrodes, including the Richmar brand, as well as iontophoresis electrodes in small (1.5 mL) and medium (2.5 mL) sizes, supplied in boxes of 12. These devices are designed for medical applications requiring controlled electrical stimulation or iontophoresis therapy.
The company’s products are classified under Class I and Class II regulatory categories, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. 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 Clearlake-Tech Inc. manufacture?
Clearlake-Tech Inc. specializes in reusable transcutaneous electrical stimulation electrodes, primarily under the Richmar brand. Additionally, they produce iontophoresis electrodes in two sizes: small (1.5 mL) and medium (2.5 mL), both packaged in boxes of 12. These devices are designed for medical applications involving controlled electrical stimulation or iontophoresis therapy.
Where is Clearlake-Tech Inc. based?
Clearlake-Tech Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and distribution, as it operates within the U.S. healthcare system and adheres to its regulatory standards.
Which regulatory registries list Clearlake-Tech Inc.’s devices?
Clearlake-Tech Inc.’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) system, which tracks devices in the United States. These listings help ensure transparency and traceability for authorized devices.
How are Clearlake-Tech Inc.’s devices classified under medical device regulations?
Clearlake-Tech Inc.’s devices fall into Class I and Class II regulatory classifications. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory scrutiny and labeling requirements for each product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 205, Highway 22 East, Clear Lake, United States
- Website
- clearlake-tech.com
- —
- —
- [email protected]
- Phone
- 16058746200
- PRRC Contact
- Amaris Ajamil
- EUDAMED SRN
- US-MF-000010642
- FDA FEI Number
- —
- DUNS Number
- 137311285
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Richmar | 400-856 | FDA UDI | Class II | Active |
| Richmar | 400-863 | FDA UDI | Class II | Active |
| Richmar | 400-862 | FDA UDI | Class II | Active |
| Richmar | 400-865 | FDA UDI | Class II | Active |
| Richmar | 400-861 | FDA UDI | Class II | Active |
| Richmar | 400-851 | FDA UDI | Class II | Active |
| Richmar | 400-882 | FDA UDI | Class II | Active |
| Richmar | 400-855 | FDA UDI | Class II | Active |
| Richmar | 400-852 | FDA UDI | Class II | Active |
| Richmar | 400-881 | FDA UDI | Class II | Active |
| Iontophoresis Electrode, Medium Standard 2.5 mL, Box of 12 | 199335-001 | EUDAMED | Class I | Active |
| Iontophoresis Electrode, Small 1.5 mL, Box of 12 | 199332-001 | EUDAMED | Class I | Active |
| Iontophoresis Electrode, Large 4.0 mL, Packet | 199336-001 | EUDAMED | Class I | Active |
| Iontophoresis Electrode, Medium Butterfly 2.0 mL, Box of 12 | 199334-001 | EUDAMED | Class I | Active |
| Iontophoresis Electrode, Large 4.0 mL, Box of 12 | 199336-001 | EUDAMED | Class I | Active |
| Iontophoresis Electrode, Medium Butterfly 2.0 mL, Packet | 199334-001 | EUDAMED | Class I | Active |
| Iontophoresis Electrode, Small 1.5 mL, Packet | 199332-001 | EUDAMED | Class I | Active |
| Iontophoresis Electrode, Medium Butterfly 2.0 mL | 199334-001 | EUDAMEDFDA UDI | Class I | Active |
| Iontophoresis Electrode, Medium Standard 2.5 mL | 199335-001 | EUDAMEDFDA UDI | Class I | Active |
| Iontophoresis Electrode, Small 1.5 mL | 199332-001 | EUDAMEDFDA UDI | Class I | Active |
| Iontophoresis Electrode, Medium Standard 2.5 mL, Packet | 199335-001 | EUDAMED | Class I | Active |
| Iontophoresis Electrode, Large 4.0 mL | 199336-001 | EUDAMEDFDA UDI | Class I | Active |
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