Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042277215

FEI Number

3042277215

Entity Name

SHENZHEN LINGLU HONGTU TECHNOLOGY CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 204, 2nd Floor, No. 01 Workshop, New World Industrial Park, Vanke City Community, Bantian Street, Longgan, Shenzhen Guangdong 518129, CN

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Shenzhen Linglu Hongtu Technology Co., Ltd (Owner Number: 10094324)

Owner / Operator Contact Address

Room 204, 2nd Floor, No. 01 Workshop, New World Industrial Park, Vanke City Community, Bantian Street, Longgan, Shenzhen, CN-GD 518129, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Upside Down Peri Bottle Postpartum Catch-All Pads Disposable postpartum underwear Herbal perineal cooling pad liners Postpartum reusable hot & cold packs Model PREK-001-US; GRFULDHB007V3-US; PMBEK-001-US Ultimate postpartum essentials kit Model PREK-001-US; GRFULDHB007V3-US; PMBEK-001-US Postpartum recovery essentials kit Model PREK-001-US; GRFULDHB007V3-US; PMBEK-001-US Postpartum mom & baby essentials kit Model PREK-001-US; GRFULDHB007V3-US; PMBEK-001-US Sinus Saline Nasal Spray Model HSP001 Baby Nasal Care Kit Model PNK01 Portable Nebulizer Model EWH01 Gas & Colic reliever Model CR01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2026-01-13
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2026-01-13
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2026-01-13
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2026-01-16
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2026-01-13
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2026-01-13
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2026-01-13

Official Correspondent

Jun wen Xie

US Agent Details

Anna Sun Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Shenzhen Linglu Hongtu Technology Co., Ltd

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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

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

Similar Registrations

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3003965134	RECE INTERNATIONAL CORP.	Miami Lakes, FL, US
3023229437	TESLA BIOHEALING, INC.	Milford, DE, US
1043646	Medegen Medical Products	GALLAWAY, TN, US
3011209790	NINGBO ALBERT NOVOSINO CO., LTD.	Yuyao Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042277215. Last updated year: 2026. Please use registration number 3042277215 when referencing this establishment in official correspondence.