Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009348823

FEI Number

3009348823

Entity Name

ManukaMed Limited Partnership

City/State/Country

Masterton Wellington, NZ

Establishment Address

3 Edwin Feist Place, Masterton Wellington 5810, NZ

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Gentell (Owner Number: 10039061)

Owner / Operator Contact Address

180 Rittenhouse Circle, Yardley, PA 19067, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2011-12-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2011-12-06
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2021-02-01

Official Correspondent

No official correspondent registered.

US Agent Details

Jonathan Scarlet Business: ManukaMed USA, LLC Email: Jono.Scarlet@Gentell.com Phone: (615) 5132999

Related Public Records

Same Entity

Gentell

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009348823. Last updated year: 2026. Please use registration number 3009348823 when referencing this establishment in official correspondence.