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Sign in to claim this brandACTIVATEK INC.
US
Last updated May 23, 2026
What ACTIVATEK INC. makes
Activatek Inc. manufactures transdermal drug-delivery systems using iontophoresis technology, including adhesive patches and portable generator devices designed to enhance medication absorption through the skin. Their products are configured for controlled dosing of medications such as nitroglycerin, with variations in size and sample units for research or clinical use.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) pathway and listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, where the manufacturer is based.
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 Activatek Inc. manufacture?
Activatek Inc. specializes in transdermal drug-delivery systems using iontophoresis technology. Their primary products include adhesive patches (like the ActivaPatch series) and portable generator devices (such as the ActivaDose II) designed to enhance medication absorption through the skin. These devices are typically configured for controlled dosing of medications, such as nitroglycerin, and may include variations like sample units for research or clinical testing.
Where is Activatek Inc. based, and where are their devices intended for use?
Activatek Inc. is based in the United States. Their devices are specifically designed and authorised for use within the U.S. regulatory framework, which governs their classification and compliance requirements.
How are Activatek Inc.’s devices classified under FDA regulations?
Activatek Inc.’s devices fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The company’s products are authorised through the 510(k) pathway, which involves demonstrating substantial equivalence to a legally marketed predicate device.
Are Activatek Inc.’s devices listed in any regulatory databases?
Yes, Activatek Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring traceability and compliance with regulatory requirements. Additionally, their products are referenced in the FDA’s 510(k) submissions, which document their authorisation process.
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
- 790584176
Catalogue (21)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trivarion | 001-20 | FDA UDI | Class II | Active |
| ActivaDose II | 001-48 | FDA UDI | Class II | Active |
| Trivarion | 001-15 | FDA UDI | Class II | Active |
| Trivarion Large Sample | 00135-SAMPLE | FDA UDI | Class II | Active |
| ActivaPatch IontoGo 4.0 Sample | 00150-SAMPLE | FDA UDI | Class II | Active |
| Norco | NC89255B | FDA UDI | Class II | Active |
| Trivarion | 001-60 | FDA UDI | Class II | Active |
| ActivaPatch IontoGo 12.0 | 001-90 | FDA UDI | Class II | Active |
| ActivaPatch IntelliDose 2.5 Sample | 00140-SAMPLE | FDA UDI | Class II | Active |
| Trivarion | 001-35 | FDA UDI | Class II | Active |
| ActivaPatch | 001-40 | FDA UDI | Class II | Active |
| ActivaPatch IontoGo 4.0 | 001-50 | FDA UDI | Class II | Active |
| Trivarion Medium & Butterfly Sample | TRVN-SA | FDA UDI | Class II | Active |
| Norco | NC89251B | FDA UDI | Class II | Active |
| Norco | NC89250B | FDA UDI | Class II | Active |
| Norco | NC89252B | FDA UDI | Class II | Active |
| Trivarion Small Sample | 00115-SAMPLE | FDA UDI | Class II | Active |
| ActivaPatch IontoGo 12.0 Sample | 00190-SAMPLE | FDA UDI | Class II | Active |
| Trivarion Buffered Iontophoresis Electrode System | K061522 | FDA 510(k) | Class II | Active |
| Activapatch | K091326 | FDA 510(k) | Class II | Active |
| Activapatch Et Iontophoresis Patch | K132832 | FDA 510(k) | Class II | Active |
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