Data / Medical devices / Brazil / Kolplast Ci Ltda
Kolplast Ci Ltda: FDA-registered device maker in Itupeva Sao Paulo, Brazil, 3 510(k) clearances
Kolplast Ci Ltda is registered with the FDA (registration 8044093) in Itupeva Sao Paulo, Brazil. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 13, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8044093
- FEI number
- 3005729015
- Address
- Estrada Municipal Benedito De Souza #418 Bairro Da Mina, Itupeva Sao Paulo, Brazil, 13299-364
- Owner or operator
- Kolplast CI Ltda (9005455)
- Roles
- Manufacturer
- First device listed
- June 3, 1992
- Registered through
- 2026
- Brand names listed
- CELLPRESERV CYTOCENTRIFUGE, CellPreserv Filter, CellPreserv Glass Slide, CellPreserv Preservation Solution, KOLPLUX System, Kolplast Cervical Sample Collection Kit, Kolplast Rectosigmoidoscope, Kolplast Vaginal Speculum and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Manufacturer | accessdata.fda.gov |
| Cytocentrifuge | IFB | 1 | Manufacturer | accessdata.fda.gov |
| Filters, Cell Collection, Tissue Processing | KET | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Surgical | FTD | 2 | Manufacturer | accessdata.fda.gov |
| Preservative, Cytological | LEA | 1 | Manufacturer | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Manufacturer | accessdata.fda.gov |
| Spatula, Cervical, Cytological | HHT | 2 | Manufacturer | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Manufacturer | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal | HIB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 13, 2017 | K153128 | Kolplast Cervical Sample Collection Kit | HHT | Substantially Equivalent | Kolplast CI SA | accessdata.fda.gov |
| September 15, 2011 | K110766 | KOLPLUX SYSTEM | HIB | Substantially Equivalent | Kolplast CI Ltda | accessdata.fda.gov |
| December 19, 1997 | K973853 | KOLPLAST VAGINAL SPECULUM | HIB | Substantially Equivalent | Kolplast Comercial E Industrial Ltda | accessdata.fda.gov |
Compare with other makers
- All makers of Speculum, Rectal
- All makers of Speculum, Vaginal, Nonmetal
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Slides, Microscope
- All makers of Spatula, Cervical, Cytological
- All makers of Preservative, Cytological
Updated January 13, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.