Data / Medical devices / Sweden / Nidacon International AB
Nidacon International AB: FDA-registered device maker in MOLNDAL Vastra Gotaland, Sweden, 10 510(k) clearances
Nidacon International AB is registered with the FDA (registration 9616005) in MOLNDAL Vastra Gotaland, Sweden. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 20, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616005
- FEI number
- 3004848623
- Address
- Flojelbergsgatan 16B, MOLNDAL Vastra Gotaland, Sweden, SE-431 37
- Owner or operator
- NIDACON INTERNATIONAL AB (9033529)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 2, 1998
- Registered through
- 2026
- Brand names listed
- CryoFloater Straw-CFS-001, CryoFloater Vial-CFV-001, NidOil-NO-100, NidOil-NO-400, PURESPERM BUFFER-PSB-100, PURESPERM WASH-PSW, PURESPERM WASH-PSW-020, PURESPERM WASH-PSW-100 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Eosin Y | HYB | 1 | Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction | MQK | 2 | Manufacturer | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 20, 2014 | K131145 | PROINSERT | MQK | Substantially Equivalent | Nidacon International AB | accessdata.fda.gov |
| June 15, 2010 | K092107 | VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 | MQL | Substantially Equivalent | Nidacon International AB | accessdata.fda.gov |
| November 8, 2002 | K023206 | SPERM CRYOPROTEC | MQL | Substantially Equivalent | Nidacon International AB | accessdata.fda.gov |
| August 10, 2001 | K011607 | SPERMCATCH | MQL | Substantially Equivalent | Nidacon International AB | accessdata.fda.gov |
| August 3, 2001 | K012123 | NIDOIL | MQL | Substantially Equivalent | Nidacon International AB | accessdata.fda.gov |
| July 12, 2001 | K011606 | PURESPERM BUFFER | MQL | Substantially Equivalent | Nidacon International AB | accessdata.fda.gov |
| November 21, 2000 | K002630 | PURESPERM WASH | MQL | Substantially Equivalent | Nidacon International AB | accessdata.fda.gov |
| November 20, 2000 | K002623 | PURESPERM 40 AND PURESPERM 80 | MQL | Substantially Equivalent | Nidacon International AB | accessdata.fda.gov |
| January 14, 1999 | K984172 | MODIFICATION OF PURESPERM | MQL | Substantially Equivalent | Nidacon International AB | accessdata.fda.gov |
| June 23, 1998 | K980814 | PURESPERM | MQL | Substantially Equivalent | Nidacon International AB | accessdata.fda.gov |
Compare with other makers
Updated February 20, 2014. 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.