FDA Device Establishments · JSON-LD · Markdown
FEI 3003775404 · Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3003775404 |
|---|---|
| Owner / Operator | BIOPTRON AG (#9052406) |
| Address | SIHLEGGSTRASSE 23, --, WOLLERAU Schwyz, CH-8832, CH |
| Mandatory US Agent | REGULATORY INSIGHT, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NHN |
| Regulation § (21 CFR) | 890.5500 |
| Proprietary names | BIOPTRON MedAll; BIOPTRON PRO 1 (BPro1) Light Therapy System; BIOPTRON Pro (BPro) Light Therapy System; BIOPTRON 2 (B2) Light Therapy System; BIOPTRON Compact III (BCIII) Light Therapy System |
Source: openFDA. Public-domain (CC0).