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Sign in to claim this brandRLR eyewear GesmbH
US
Last updated May 23, 2026
What RLR eyewear GesmbH makes
RLR eyewear GesmbH manufactures spectacle frames and tinted non-prescription spectacles under the Robert La Roche brand. These products are designed for general eyewear use without prescription adjustments, including both standard and tinted lenses.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from 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 RLR eyewear GesmbH manufacture?
RLR eyewear GesmbH specializes in spectacle frames and tinted non-prescription spectacles, all sold under the Robert La Roche brand. These devices are intended for general eyewear use and do not require prescription adjustments, making them suitable for consumers seeking stylish, functional eyewear without medical intervention.
Where is RLR eyewear GesmbH based, and what does that mean for its devices?
RLR eyewear GesmbH is based in the United States. This means the company operates under U.S. regulatory frameworks, and its devices are subject to compliance with FDA requirements. The location also influences distribution, manufacturing standards, and potential market access within the U.S. and internationally.
Which regulatory registries list RLR eyewear GesmbH’s devices, and why is that important?
RLR eyewear GesmbH’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry is critical because it ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and patients to verify device authenticity, recall history, and compliance with U.S. medical device regulations.
How are RLR eyewear GesmbH’s devices classified under U.S. regulations?
RLR eyewear GesmbH’s devices fall under FDA’s Class I classification. This classification applies to low-risk products like spectacle frames and non-prescription tinted spectacles, which pose minimal risk to users. Class I devices typically require general controls (e.g., proper labeling, manufacturing practices) but do not need pre-market approval, as they are deemed safe and effective through established standards.
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
- 300407083
Catalogue (363)
Page 8 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Robert La Roche | RLR504T-04 | FDA UDI | Class I | Active |
| Robert La Roche | CRS007-13 | FDA UDI | Class I | Active |
| Robert La Roche | RLR1106-07 | FDA UDI | Class I | Active |
| Robert La Roche | RLR1134S-06 | FDA UDI | Class I | Active |
| Robert La Roche | RLR1137-01 | FDA UDI | Class I | Active |
| Robert La Roche | RLRS343RX-013 | FDA UDI | Class I | Active |
| Robert La Roche | RLR504T-01 | FDA UDI | Class I | Active |
| Robert La Roche | RLR1142-01 | FDA UDI | Class I | Active |
| Robert La Roche | CR010-02 | FDA UDI | Class I | Active |
| Robert La Roche | RLRS343-05 | FDA UDI | Class I | Active |
| Robert La Roche | RLR1136-02 | FDA UDI | Class I | Active |
| Robert La Roche | RLRS353-04 | FDA UDI | Class I | Active |
| Robert La Roche | RLR1108-013 | FDA UDI | Class I | Active |
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