BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    ManukaMed Limited Partnership

    Reg #: 3009348823 · FEI: 3009348823 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    25
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ManukaMed Limited Partnership
    Registration Number
    3009348823
    FEI Number
    3009348823
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3 Edwin Feist Place
    City
    Masterton Wellington
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K102659

    Owner / Operator

    Firm Name
    Gentell
    Operator Number
    10039061
    Address
    180 Rittenhouse Circle
    City
    Yardley
    State
    PA
    Postal Code
    19067
    Country
    US

    US Agent

    Business Name
    ManukaMed USA, LLC
    Contact Name
    Jonathan Scarlet
    Address
    718 Thompson Lane, Suite 108-227
    City
    Nashville
    State
    TN
    ZIP
    37204
    Country
    US
    Email
    [email protected]
    Phone
    615 5132999

    Products

    Device Name Product Code
    Dressing, Wound, Drug FRO
    Dressing, Wound, Hydrophilic NAC

    Proprietary Names

    199-143 McKesson, Manuka Honey Lite Super Absorbent Dressing 2 in x 2 in (5 cm x 5 cm) MM0030 Gentell Manuka Honey Fiber Select 2" x 2" (5 x 5cm) (formerly MANUKAhd Lite 2" x 2" (5 x 5cm)) 199-142 McKesson, Manuka Honey Super Absorbent Dressing 4 in x 5 in (10 cm x 12.5 cm) MM0070 Gentell Manuka Honey Fiber Dressing 2" x 2" (5cm x 5cm) (formerly MANUKAhd Super Lite 2" x 2" (5cm x 5cm)) First Honey Adhesive Dressings First Honey Adhesive Bandages ManukaMed Adhesive Bandages ManukaMed Adhesive Dressings MM0013 Gentell Manuka Honey Fiber Premium 2" x 2" (5 x5cm) (formerly MANUKAhd 2" x 2" (5 x5cm)) MM0071 Gentell Manuka Honey Fiber Dressing 4" x 5" (10cm x 12.5cm) (formerly MANUKAhd Super Lite 4" x 5" (10cm x 12.5cm)) MM0031 Gentell Manuka Honey Fiber Select 4" x 5" (10 x 12.5cm) (formerly MANUKAhd Lite 4" x 5" (10 x 12.5cm)) 199-141 McKesson, Manuka Honey Super Absorbent Dressing 2 in x 2 in (5 cm x 5 cm) MM0017 Gentell Manuka Honey Fiber Premium 4" x 5" (10 x 12.5cm) (formerly MANUKAhd 4" x 5" (10 x 12.5cm)) 199-144 McKesson, Manuka Honey Lite Super Absorbent Dressing 4 in x 5 in (10 cm x 12.5 cm) MM0049 Gentell Manuka Honey Wound Dressing 15g (formerly MANUKApli 15g) 199-132 McKesson, Manuka Honey Wound Dressing 2 x 0.5oz (15g) MM0051 Gentell Manuka Honey Wound Dressing 44g (formerly MANUKApli 44g) MM0048 Gentell Manuka Honey Wound Dressing 20g (formerly MANUKApli 20g) First Honey Sterile Honey Ointment 199-135 McKesson, Manuka Honey Wound Dressing 1.5oz (44g) 199-140 McKesson, Manuka Honey Roll Non-Adherent Dressing 4 in x 48 in (10 cm x 122 cm) MM0011 Gentell Manuka Honey Non-Adherent Dressing 4" x 8" (10 x 20cm) (formerly MANUKAtex 4" x 8" (10 x 20cm)) MM0010 Gentell Manuka Honey Non-Adherent Dressing 4" x 5" (10 x 12.5cm) (formerly MANUKAtex 4" x 5" (10 x 12.5cm)) MM0012 Gentell Manuka Honey Non-Adherent Wrap 4" x 48" (10 x 122cm) (formerly MANUKAtex 4" x 48" (10 x 122cm)) 199-138 McKesson, Manuka Honey Sheet Non-Adherent Dressing 4 in x 5 in (10 cm x 12.5 cm)

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility