Data / Medical devices / New Zealand / NZ Biomed Limited
NZ Biomed Limited: FDA-registered device maker in Dunedin Otago, New Zealand, 14 510(k) clearances
NZ Biomed Limited is registered with the FDA (registration 3042172882) in Dunedin Otago, New Zealand. It lists 19 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 19, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3042172882
- Address
- 59 Prospect Bank, Dunedin Otago, New Zealand, 9010
- Owner or operator
- NZ Biomed Limited (10094475)
- Roles
- Exporter to the US
- First device listed
- December 29, 2014
- Registered through
- 2026
- Brand names listed
- BF-1TH190, BF-H190, BF-MP190F, BF-P190, CF-HQ190L, GF-UCT180, GF-UE160-AL5, GIF-1TH190 and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| September 19, 2025 | K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) | FDT | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| June 23, 2025 | K250862 | EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| June 19, 2024 | K232997 | EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 | FDS | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| November 9, 2020 | K203128 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS | IYN | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| September 6, 2019 | K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | PSV | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| April 30, 2018 | K172726 | EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| October 9, 2015 | K152036 | SOMATOM Definition Edge, SOMATOM Definition AS/AS+ | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 29, 2013 | K131780 | EVIS EXERA III VIDEO SYSTEM | FDF | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| January 10, 2013 | K121959 | EVIS EXERA III VIDEO SYSTEM | EOQ | Substantially Equivalent | Olympus Medical Systems Corp. | accessdata.fda.gov |
| December 11, 2012 | K123317 | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N | FDS | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| February 16, 2012 | K112680 | EVIS EXERA III VIDEO SYSTEM | FDF | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| June 17, 2010 | K093395 | OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE | IYN | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| March 25, 2008 | K071254 | SMALL INTESTINAL VIDEOSCOPE SYSTEM | FDA | Substantially Equivalent | Olympus Medical Systems Corporation | accessdata.fda.gov |
| July 1, 2005 | K051541 | GF-UE160-AL5 ULTRASOUND ENDOSCOPE | FDF | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
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Updated September 19, 2025. 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.