Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027605322

FEI Number

3027605322

Entity Name

HONG KONG LUTE TECHNOLOGY CO., LIMITED

City/State/Country

HONG KONG, HK

Establishment Address

Room 803B, 8/F, West Bund International Building, 290-296 Yuen Chau Street, Cheung Sha Wan, Kowloon, HONG KONG 000000, HK

Establishment Type(s)

Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HONG KONG LUTE TECHNOLOGY CO., LIMITED (Owner Number: 10088201)

Owner / Operator Contact Address

Room 803B, 8/F, West Bund International Building, 290-296 Yuen Chau Street, Cheung Sha Wan, Kowloon, HONG KONG, HK-NOTA 000000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233880

PMA Number

N/A

All Registered Proprietary Names

Momcozy Wearable Breast Pump (Model M5); Hydrogel Breast Pads, Model BF009 Momcozy Baby Electric Nasal Aspirator, BN02 Electric Baby Nasal Aspirator - BN006 Nursing pads Disposable nursing pads Wearable Breast Pump (Model P3); MeggO Maternity Ball (Model: MeggO) Wearable Breast Pump (Model P10); Wearable Breast Pump (Model Y10); Peri bottle, PK003 Breast Warmers, BF007 Instant Cold Soothing Pad, PK004 Momcozy Maternity Belt, YB001 Cold Soothing Ice Pad - PK008 Momcozy Colostrum Collector - BC002 Tongue brush suit - MCTB01 Wearable Breast Pump (Model R12); Momcozy Lactation Massager - A1Pro Momcozy Lactation Massager - LA01 Momcozy Lactation Massager - A1 Momcozy Lactation Massager Momcozy Lactation Massager - LM01, LM02, LM03, LM04 Momcozy Breast care set - BF020 360° silicone toothbrush - MCST01 Baby 2-in-1 Nasal Aspirator with Sprayer - BN005 Baby Nasal Aspirator (Model BN02) Baby Medicine Dispenser Momcozy Wearable Breast Pump (Model S9 Pro); Momcozy Wearable Breast Pump (Model S12 Pro); Hand Teether - BY005 BY006 BY007 Water-fillable Icy Teethers - BY001 Momcozy Wearable Breast Pump (BP137, BP141)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-06-08
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2023-11-15
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2023-11-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-12-25
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	General Hospital	Class 1	880.5630	2023-11-15
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-07-03
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	2026-02-25
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-06-09
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2023-11-15
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2023-11-15
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2024-01-26
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2026-01-07
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2024-04-21
OHH	Breast Pump Kit	Obstetrics/Gynecology	Class 2	884.5160	2025-09-25
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2024-03-22
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-06-09
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2023-11-15
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2024-03-22
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2024-05-06
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2026-04-13
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2023-11-15
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-06-13
KKO	Ring, Teething, Fluid-Filled	Dental	Class 2	872.5550	2024-04-17
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2024-04-22

Official Correspondent

Athena Pan

US Agent Details

Amy Dong Business: ROOT TECHNOLOGY LTD. Email: regulatory@momcozy.com Phone: (424) 5137016

Related Public Records

Same Entity

HONG KONG LUTE TECHNOLOGY CO., LIMITED

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
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18

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-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027605322. Last updated year: 2026. Please use registration number 3027605322 when referencing this establishment in official correspondence.