CE & ISO 13485 Certified Ankle Support Fixation Brace (108 Degree)

Name: CE & ISO 13485 Certified Ankle Support Fixation Brace (108 Degree)
Brand: Leihu (Henan) Medical Devices Co., Ltd.
SKU: 2197773712

Henan, ChinaLeihu (Henan) Medical Devices Co., Ltd.

US$60.00

20-100 Sets

US$55.00

101-500 Sets

US$50.00

501-1,000 Sets

US$48.00

1,001+ Sets

Product specifications

LH-A201(108 Degree)

Sample price:US$65.00/set.Request sample

Product profile

Customization

Available

Customized

Certification

ISO, CE

Model NO.

LH-A201(108Degree)

Condition

New

Usage

Fracture Fixation

Using Site

Foot / Ankle Joint (108°),Distal Tibia and Fibula

Type

Splint Fixation

Material

TPU Mesh Sleeve + Two-Component Curing Liquid

Other Tests

Biocompatibility Test Report

Patent Certificate

Utility Model Patent Certificate;Design Patent Cer

Color Customization

Blue / Green / Pink / Camouflage

Transport Package

Standard Export Carton

Specification

Trademark

LEIGERY

Origin

Luohe City, Henan Province, China

HS Code

9201100000

Production Capacity

10, 000 Sets/Month

Key features

Breathable TPU Mesh Sleeve:Ventilated mesh keeps the limb comfortable through extended wear and warm climates; waterproof and sweatproof ,wearers can shower with it on, and daily cleaning is easy.

Radiolucent Design:X-ray translucent material allows clinicians to image the fracture site without removing the brace

Adjustable & Re-moldable:Fit can be re-adjusted across recovery stages, and the brace can be re-heated and re-molded to refit.

Medical-grade TPU, low allergenicity against the skin

Easy to operate:2-3 min to form, 10 min to set

Company profile

Leihu (Henan) Medical Devices Co., Ltd.

Henan, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 2 Years CertifiedNearest Port: Qingdao Port CertifiedTerms of Payment: LC, T/T, D/P, etc.

About Our Factory & Business Background

AddressNo. 002, North Wanquanhe Road, East Zhongshan Road, Economic and Technological Development Zone, Luohe City, Henan Province

Plant Area3300 square meters

Number of Employees17

Registered Capital1,000,000 RMB

International Commercial Terms(Incoterms)FOB, CIF, CFR, EXW

Average Lead TimePeak Season Lead Time: within 15 workdays Off Season Lead Time: within 15 workdays

Minimum Order Quantity50 Sets

Supply Chain Partners9

Our Production Capability & Technical Expertise

Main ProductsMedical External Fixation Braces; Stretcher

Production Lines2

Production MachinesCutting Machine, High frequency splicing machine, High frequency takeover machine

QA/QC inspectors1 people

Inspection Type for Finished Products100% inspection(Visual inspection & Function inspection)

Inspection Method for Finished ProductsHave instructions and uniformly followed

R&D Engineers1 people

Traceability of Raw MaterialsYes

Own BrandYes

Our Industry Experience & Global Business Record

Year of Establishment2024-01-09

Main MarketsSoutheast Asia/ Mideast, Domestic

Repeat Buyers Choice30%~50%

Number of Foreign Trading Staff3

Overseas Agent/BranchNo

New Products Launched in Last yearNo

Our Certifications, Standards & Industry Recognition

Management System CertificationOthers

Product CertificationOthers

Cooperated with Fortune 500No

Product Q&A

Q:What is the LEIGERY LH-A201 and what is it used for?

The LEIGERY Ankle Brace (Model LH-A201, fixed 108 Degree angle) is a Class I orthopedic external fixation device engineered as a comfortable, lightweight alternative to traditional plaster casts. It provides stable, adjustable immobilization for ankle and distal tibia / fibula fracture management and post-operative recovery, and is supplied to orthopedic clinics, hospitals, rehabilitation centers, medical device distributors and importers.

Q:What certifications does it hold?

CE Declaration of Conformity; ISO 13485:2016; NMPA Class I record filing; Export Sales Certificate.

Q:How do I choose the correct size?

Four sizes are offered: S / M / L / XL, sized by limb circumference (measurement points A/B/C/D).

Q:Can we private label or customize?

Yes. OEM/ODM, private labeling and custom sizing / fixation angle / material blend are available; documentation is prepared per your target market.

Q:What is the lead time and stock position?

10,000 sets are ready in stock; standard lead time is 15-30 days from order confirmation (FOB ).