Data / Medical devices / New Zealand / ManukaMed Limited Partnership
ManukaMed Limited Partnership: FDA-registered device maker in Masterton Wellington, New Zealand, 3 510(k) clearances
ManukaMed Limited Partnership is registered with the FDA (registration 3009348823) in Masterton Wellington, New Zealand. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 24, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009348823
- Address
- 3 Edwin Feist Place, Masterton Wellington, New Zealand, 5810
- Owner or operator
- Gentell (10039061)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 6, 2011
- Registered through
- 2026
- Brand names listed
- 199-132 McKesson, Manuka Honey Wound Dressing 2 x 0.5oz (15g), 199-135 McKesson, Manuka Honey Wound Dressing 1.5oz (44g), 199-138 McKesson, Manuka Honey Sheet Non-Adherent Dressing 4 in x 5 in (10 cm x 12.5 cm), 199-140 McKesson, Manuka Honey Roll Non-Adherent Dressing 4 in x 48 in (10 cm x 122 cm), 199-141 McKesson, Manuka Honey Super Absorbent Dressing 2 in x 2 in (5 cm x 5 cm), 199-142 McKesson, Manuka Honey Super Absorbent Dressing 4 in x 5 in (10 cm x 12.5 cm), 199-143 McKesson, Manuka Honey Lite Super Absorbent Dressing 2 in x 2 in (5 cm x 5 cm), 199-144 McKesson, Manuka Honey Lite Super Absorbent Dressing 4 in x 5 in (10 cm x 12.5 cm) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer, Specification developer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | 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 |
|---|---|---|---|---|---|---|
| March 24, 2011 | K110042 | MANUKATEX | FRO | Substantially Equivalent | Manuka Medical Limited | accessdata.fda.gov |
| December 8, 2010 | K102659 | MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER | FRO | Substantially Equivalent | Manuka Medical Limited | accessdata.fda.gov |
| May 20, 2010 | K092689 | MANUKAPLI WOUND DRESSING | FRO | Substantially Equivalent | Manuka Medical Limited | accessdata.fda.gov |
Compare with other makers
Updated March 24, 2011. 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.