FDA Device Establishments · JSON-LD · Markdown
FEI 3008382007 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3008382007 |
|---|---|
| Owner / Operator | LifeScan Europe, GmbH (#10032336) |
| Address | Dammstrasse 19, CH Zug, 6300, CH |
| Mandatory US Agent | LIFESCAN US LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | NBW, LFR |
| Regulation § (21 CFR) | 862.1345 |
| Proprietary names | OneTouch Ultra Plus Test Strips; OneTouch Ultra Plus Flex Meter; OneTouch Ultra Plus Control Solution |
Source: openFDA. Public-domain (CC0).