Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017910381

FEI Number

3017910381

Entity Name

GUANGZHOU NEW DESIGN BIOTECHNOLOGY CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Office 2001-6, No.353 Yijing Road, Haizhu District, Guangzhou Guangdong 510220, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou New Design Biotechnology Co., Ltd. (Owner Number: 10079057)

Owner / Operator Contact Address

Office 2001-6, No.353 Yijing Road, Haizhu District, Guangzhou, CN-GD 510220, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TL042A TL042A WB1, WB2, WB3, WX1, WX2, WX3, WY1, WY2 ZX1, ZY1, ZY2, ZY3 TJ-608,TL142A DH153AD, LV021R, CI162AR, CI168AR, CI157AG, CI157AB,CI170A WD1, DH047A, WD3H CI191A CSG003 CI093, LK023A, LK020B, LK020A, LK026A, LK028A, LK022A, BA-JQ-C, LK020C,LK020D,LV2101A,LV2101B,LV2102A,LV2102B,LV2103A,LV2103B,LV2104A,LV2104B,LV2105A,LV2105B,K022A, JT1, JT2, JT3, JT4, JB1, JB2, JX1, JX2, JX3 TE001A,TJ-608,TL142A,TE-X3,TE-F4,TC318A, TC-X3,TF-F2,TE-F3,TL318A,TL043A,TL041A, X3QB, MB1H, MX3H MX1, MX2, MB1, MB2, MB3, MB4, MB5, MX3QB, MXHQB, MX3Q, MXH, MB1Q, TL046A, TL047A, MF2a, MF2b, MXHQY, MB6, MF5A, XHQB, TL042A, GX1, P10 DH013ASH , CI3201AF TE301A TF201A, TL321AF KF003A,KF004A,WM133AF,DH153AF TL031B

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OTX	Foot Wrap For Treating Restless Leg Syndrome Symptoms	Physical Medicine	Class 1	890.5760	2024-06-17
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2022-05-20
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2020-11-17
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2021-06-24
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2021-07-12
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2021-07-12
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2023-02-21
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2021-12-22
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2022-03-11

Official Correspondent

Jiaru Liu

US Agent Details

Jessie Yao Business: MEDRIGHT TECH INC Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Guangzhou New Design Biotechnology 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 3017910381. Last updated year: 2026. Please use registration number 3017910381 when referencing this establishment in official correspondence.