Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021841055

FEI Number

3021841055

Entity Name

MERET USA LLC

City/State/Country

Newport Beach, CA, US

Establishment Address

151 SHIPYARD WAY, SUITE B, Newport Beach, CA 92663, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

MERET USA LLC (Owner Number: 10084520)

Owner / Operator Contact Address

3406 VIA LIDO STE. 1A #31, Newport Beach, CA 92663, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MERET MERET MERET MERET MERET MERET MERET MERET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-10-24
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-10-28
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2024-10-24
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2024-10-24
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2024-10-24
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2024-10-24
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2022-03-04
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-10-24
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-10-24
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-10-24
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-10-24

Official Correspondent

SCOTT DECKER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MERET USA LLC

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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21
K981039	Sri Johani Sdn. Bhd.	POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)	1998-04-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021841055. Last updated year: 2026. Please use registration number 3021841055 when referencing this establishment in official correspondence.