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Sign in to claim this brandErgodyne
US
Last updated May 23, 2026
What Ergodyne makes
The company produces tinted non-prescription spectacles designed for general use, including a range of stylized models marketed under the Skullerz brand. These products are intended for visual correction and protection without requiring a prescription, featuring various lens tints and designs.
The portfolio is classified under FDA’s Class I medical devices and is listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory requirements for non-prescription eyewear.
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 Ergodyne manufacture?
Ergodyne specializes in tinted non-prescription spectacles, designed for general visual correction and protection without requiring a prescription. These devices are intended for everyday use and include stylized models under the Skullerz brand, featuring various lens tints and designs.
Where is Ergodyne based, and does its location affect its regulatory compliance?
Ergodyne is headquartered in the United States, where it develops and manufactures its products. Since its devices fall under FDA jurisdiction, the company must comply with U.S. regulatory requirements for non-prescription eyewear, including classification and listing in relevant databases.
How are Ergodyne’s devices classified by regulatory authorities, and why?
Ergodyne’s tinted non-prescription spectacles are classified as FDA Class I medical devices. This classification applies because the products are considered low-risk, intended for general use without active controls or invasive procedures, and do not require stringent pre-market approval.
Are Ergodyne’s devices listed in any regulatory registries, and if so, which ones?
Yes, Ergodyne’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I products, including non-prescription spectacles, by assigning a standardized identifier to each device model.
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
- 108665142
Catalogue (235)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skullerz | BALDR | FDA UDI | Class I | Active |
| Skullerz | BALDR-AF | FDA UDI | Class I | Active |
| Skullerz | THOR | FDA UDI | Class I | Active |
| Skullerz | SKOLL-AF | FDA UDI | Class I | Active |
| Skullerz | LOKI-PZ | FDA UDI | Class I | Active |
| Skullerz | BALDR-AF | FDA UDI | Class I | Active |
| Skullerz | BALDR | FDA UDI | Class I | Active |
| Skullerz | LOKI-AF | FDA UDI | Class I | Active |
| Skullerz | DAGR-AF | FDA UDI | Class I | Active |
| Skullerz | DELLENGER | FDA UDI | Class I | Active |
| Skullerz | DAGR-AF | FDA UDI | Class I | Active |
| Skullerz | DAGR | FDA UDI | Class I | Active |
| Skullerz | BALDR-AFAS | FDA UDI | Class I | Active |
| Skullerz | AEGIR-MI | FDA UDI | Class I | Active |
| Skullerz | THOR-PZ | FDA UDI | Class I | Active |
| Skullerz | AEGIR-MI | FDA UDI | Class I | Active |
| Skullerz | VALI | FDA UDI | Class I | Active |
| Skullerz | THOR | FDA UDI | Class I | Active |
| Skullerz | DAGR-AF | FDA UDI | Class I | Active |
| Skullerz | LOKI-AF | FDA UDI | Class I | Active |
| Skullerz | AEGIR-AFASM | FDA UDI | Class I | Active |
| Skullerz | DELLENGER-AFAS | FDA UDI | Class I | Active |
| Skullerz | OSMIN-AFAS | FDA UDI | Class I | Active |
| Skullerz | AEGIR-MI | FDA UDI | Class I | Active |
| Skullerz | DAGR | FDA UDI | Class I | Active |
| Skullerz | ODIN | FDA UDI | Class I | Active |
| Skullerz | ODIN | FDA UDI | Class I | Active |
| Skullerz | OSMIN | FDA UDI | Class I | Active |
| Skullerz | SAGA-AF | FDA UDI | Class I | Active |
| Skullerz | THOR-AFAS | FDA UDI | Class I | Active |
| Skullerz | AEGIR-MI | FDA UDI | Class I | Active |
| Skullerz | ODIN | FDA UDI | Class I | Active |
| Skullerz | THOR-PZ | FDA UDI | Class I | Active |
| Skullerz | DAGR-PZ | FDA UDI | Class I | Active |
| Skullerz | ODIN-PZ | FDA UDI | Class I | Active |
| Skullerz | AEGIR-AFASM | FDA UDI | Class I | Active |
| Skullerz | SAGA | FDA UDI | Class I | Active |
| Skullerz | ODIN-PZ | FDA UDI | Class I | Active |
| Skullerz | AEGIR-MI | FDA UDI | Class I | Active |
| Skullerz | AEGIR-AFASM | FDA UDI | Class I | Active |
| Skullerz | VALI-AFAS | FDA UDI | Class I | Active |
| Skullerz | DAGR-AF | FDA UDI | Class I | Active |
| Skullerz | ODIN-AF | FDA UDI | Class I | Active |
| Skullerz | DAGR | FDA UDI | Class I | Active |
| Skullerz | THOR-AF | FDA UDI | Class I | Active |
| Skullerz | BALDR-AF | FDA UDI | Class I | Active |
| Skullerz | BALDR-AF | FDA UDI | Class I | Active |
| Skullerz | OSMIN | FDA UDI | Class I | Active |
| Skullerz | SKOLL | FDA UDI | Class I | Active |
| Skullerz | ODIN | FDA UDI | Class I | Active |
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