Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035858921

FEI Number

3035858921

Entity Name

SHANGHAI LANGE MEDTECH CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

1st floor, Building 22, 1500 Duhui Road, Minhang District, Shanghai 201108, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Lange Medtech Co., Ltd. (Owner Number: 10092484)

Owner / Operator Contact Address

1st floor, Building 22, 1500 Duhui Road, Minhang District, Shanghai, CN-SH 201108, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bone Chisel, 5x250, 5x250x35°, 5x250x35° ,5x250x20° ,5x250x38°, 5x310, 8x8x295 Retractor, 12x188 12x188 6x186 12x188 194 194 193 ?15x188 ?15x188x120° ?15x188x120° ?10x60 ?15x60 ?15. Nerve Probe,?1.5x220 ?1.5x220 ?1.5x240 Dilator inner tubes, S08-01, S08-03 Puncture needles, S05-02, S05-03, S05-04, S05-05, S05-08, S05-09, S05-10 Balloon Inflation Devices, S06-30 Guide Wires, S09-01 Dilator outer tubes, S10-01, S10-02, S10-03 Bone drills, S04-30, S04-34 Hammer,220 Punches, 4x175 Bone Biopsy Devices, 3.5x150, 3.5x200 Drainage Tube, 3.5x203, 5.5x203, 4.5x220

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-09-30
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-09-30
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-09-30
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2025-01-14
GFB	Head, Surgical, Hammer	General, Plastic Surgery	Class 1	878.4820	2025-09-30
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2025-09-30
PXO	Bone Marrow Biopsy Tray	General, Plastic Surgery	Class 1	878.4800	2025-01-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-09-30

Official Correspondent

Xin Zhou

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Shanghai Lange Medtech 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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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9610773	OLYMPUS WINTER & IBE GMBH	HAMBURG, DE
8040172	BURAQ SURGICAL CORP.	SIALKOT Punjab, PK
3009420946	HUANGHUA PROMISEE DENTAL CO., LTD	Huanghua Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035858921. Last updated year: 2026. Please use registration number 3035858921 when referencing this establishment in official correspondence.