FDA Device Establishments · JSON-LD · Markdown
FEI 3005690789 · Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3005690789 |
|---|---|
| Owner / Operator | Disera Tibbi Malzeme Lojistik Sanayi Tic. A.S. (#10090595) |
| Address | Ibni Melek OSB, Mahallesi. Tosbi , 35900, Tire Izmir, 35900, TR |
| Mandatory US Agent | CALBIOTECH, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FMH |
| Regulation § (21 CFR) | 864.3250 |
| Proprietary names | 535806 VACUSERA® 6 ml Urine Tube; 503001 VACUSERA® Urine Beaker Red Cap; 536800 VACUSERA® 10 ml Urine Tube; 503026 VACUSERA® Urine Beaker with Integrated Holder; 536828 VACUSERA® 8 ml Urine Tube - Chlorhexidine; 536810 VACUSERA® 10 ml Urine Tube - Boric Acid; 536820 VACUSERA® 10 ml Urine Tube - Chlorhexidine; 535816 VACUSERA® 6 ml Urine Tube - Boric Acid |
Source: openFDA. Public-domain (CC0).