Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030683078

FEI Number

3030683078

Entity Name

HUILING (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

No. 2 of 53-4 Xiyang Road, Tongan District, Xiamen Fujian 361100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HuiLing (Xiamen) Medical Technology Co., Ltd. (Owner Number: 10090246)

Owner / Operator Contact Address

Unit E-3, 4th Floor, Beilongxin Building, No.8 Xinfeng 2nd Road, Torch Park, Torch High-tech Zone, Xiamen, CN-FJ 361006, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

model: HL42008, specification: Universal model: HL035, specification: S-L/R, M-L/R, L-L/R XL-L/R model: HL42007, specification: Universal model: HL42001, specification: Universal model: HL047, specification: Universal Knee Orthosis model: HL045, specification: S, M, L, XL, XXL, XXXL model: HL42011, specification: Universal model: HL42003, specification: Universal model: HL018, specification: Universal model: HL017, specification: Universal model: HL036, specification: S-L/R, M-L/R, L-L/R XL-L/R model: HL023, specification: Universal model: HL024, specification: Universal model: HL051, specification: Universal model: HL052, specification: Universal Cervical Brace, Orthosis model: HL6506 , specification: Universal model: RDS15 , specification: Universal model: HL12007, specification: Universal Behind The Ear Hearing Aid( OTC), HL1ON, HL10,HL20,HL30,HL40,HL50, HL15N,HL15,HL25,HL35,HL45,HL55 IN THE EAR HEARING Aid, HL12L,HL12R,HL22L,HL22R Behind The Ear Hearing Aid( OTC), HL11N,HL11,HL21,HL31,HL41,HL51,HL11PN,HL11P,HL21P,HL31P,HL41P,HL51P Behind The Ear Hearing Aid( OTC), HL15PN,HL15P,HL25P,HL35P,HL45P,HL55P, HL15UN,HL15U,HL25U,HL350,HL450,HL.550 Behind The Ear Hearing Aid (OTC), HL22N,HL22,HL32,HL52,HL62,HL72,HL82,HL92 model: HL60241, specification: S-L/R, M-L/R, L-L/R XL-L/R model: HL52005, specification: S-L/R, L-L/R model: HL6052, specification: Universal model: HL82018, specification: Universal model: HL003, specification: Universal-L/R Lower Limb Orthosis model: HL52006, specification: S-L/R, L-L/R model: HL52015, specification: S, M, L model: HL52014, specification: S, M, L, XL model: HL82010, specification: Universal Upper Limb Orthosis model: HL048, specification: Universal model: HL13131, specification: S-L/R, L-L/R model: HL83010, specification: Universal-L/R model: HL012, specification: S, M, L, XL, XXL model: HB09, specification: S, M, L, XL, XXL Lumbo-sacral Orthosis model: HL22076, specification: Universal model: HL70002, specification: S, M, L, XL, XXL model: HL70007, specification: S, M, L, XL, XXL model: HL70006, specification: S, M, L, XL, XXL model: HL046, specification: S, M, L, XL, XXL model: HL32007, specification: Universal model: HL013, specification: S, M, L, XL, XXL model: HL70004, specification: S, M, L, XL, XXL model: BST07, specification: S, M, L, XL, XXL model: BST08, specification: S, M, L, XL, XXL model: HB10 specification: S, M, L, XL, XXL model: HL70003, specification: S, M, L, XL, XXL Chest Orthosis model: HL1903, specification: S, M, L, XL model: HL70002, specification: S, M, L, XL, XXL model: HL70004, specification: S, M, L, XL, XXL model: HL001, specification: Universal model: HL32007, specification: Universal model: HL22076, specification: Universal model: MLK01, specification: Universal model: HL027, specification: S, L model: HL86222, specification: S, M, L model: HL22003, specification: Universal model: HL060, specification: S, M, L model: HL22005, specification: Universal Finger Orthosis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2025-12-08
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2025-12-08
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2024-03-01
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2024-03-01
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2025-12-08
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2025-12-08
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2025-12-09
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2025-12-09

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

HuiLing (Xiamen) Medical Technology Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030683078. Last updated year: 2026. Please use registration number 3030683078 when referencing this establishment in official correspondence.