SGS onsite-verified orthopedic manufacturer · CE (MDR / 93/42/EEC) implants · OEM & ODM
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Company Profile

Precision Engineering, Rigorous Testing & Certified Manufacturing Excellence

Established Orthopedic Manufacturer

Zhejiang INAR Medical Co., Ltd.

Founded with a commitment to orthopedic innovation, Zhejiang INAR Medical Co., Ltd. operates a modern 29,523 m² manufacturing facility in Jinhua, Zhejiang, China. With over 22 years of technical manufacturing experience and a dedicated workforce of 632 professionals, we specialize in the complete R&D, precision CNC machining, surface treatment, quality testing, and aseptic packaging of Class II and Class III orthopedic implants and surgical instruments.

Our comprehensive production spectrum encompasses Trauma Locking Plates, Interlocking Intramedullary Nails, Interbody PEEK Cages, Spinal Pedicle Screw Systems, and Sports Medicine Arthroscopy Implants. Accredited under ISO 13485:2016, EU MDR (Regulation 2017/745), Medical Device Directive 93/42/EEC, and MDSAP, our facility undergoes regular onsite assessments by international third-party certification bodies, including SGS Group, TÜV Rheinland, and DEKRA.

Verified Factory Credentials

SGS Onsite Audited
Competitive OEM Factory
Full Customization Available
ISO 13485 QMS Certified
22+ Years Manufacturing
29,523 m²
Total Floorspace
632
Total Headcount
59
R&D Engineers
69
QA/QC Inspectors
412
Line Operators
22 Yrs
Export Experience
End-to-End Production Traceability

Standardized Manufacturing Workflow

Every orthopedic implant produced by Zhejiang INAR Medical Co., Ltd. strictly adheres to a controlled 14-step manufacturing route to ensure flawless clinical reliability and total material traceability.

State-of-the-Art Infrastructure

Equipment & Quality Control Laboratory

Zhejiang INAR Medical Co., Ltd. invests heavily in advanced multi-axis CNC lathes, high-precision surface finishing units, non-destructive testing suites, and dedicated mechanical stress testing labs.

Enterprise Strengths

Comprehensive OEM & ODM Capabilities

Designed to support global hospital tenders, brand owners, and medical device distributors with complete technical documentation, custom design, and consistent batch manufacturing.

Custom Engineering & Design

Full-scale OEM/ODM services tailored to specific anatomical requirements, custom contouring, and specialized surgical instrument trays.

Drawing-based CustomizationSupported
Sample ProcessingSupported
Private Labeling & Laser MarkingAvailable

R&D & Product Innovation

Driven by an experienced team of 59 development engineers continuously releasing new anatomical systems to address evolving surgical techniques.

R&D Engineers59 Staff
New Products / Year20+ Systems
Owned Patents & TrademarksRegistered

Advanced Production Scale

Substantial manufacturing infrastructure covering 29,523 m² with 412 skilled production line operators providing high volume stability.

Total Plant Area29,523 m²
Line Operators412 Personnel
Manufacturing Workflow100% In-House

Quality Assurance & Control

69 full-time QA/QC inspectors managing incoming material testing, in-line process checks, dye penetrant inspection, and final OQC before release.

QA/QC Inspectors69 Specialists
Dye Penetrant Testing100% Implants
Fatigue Endurance TestVerified

Global Export Experience

22 years of direct international trade experience assisting procurement partners with product registration, customs clearance, and logistical logistics.

Export History22+ Years
Nearest Shipping PortsShanghai / Ningbo
Cooperated Factories30 Partners

Direct Business Support

Our dedicated international sales team guarantees rapid inquiry turnarounds, regulatory technical dossiers, and surgical technique documentation.

Response Time≤ 4 Hours
Official Contact Email[email protected]
Order Dispatch Rate97.0% On-Time
International Compliance

Accreditations & Quality Certificates

Zhejiang INAR Medical Co., Ltd. complies with world-class quality management standards and medical device directives to empower frictionless international distribution.

ISO 13485 TÜV Rheinland Certification - Zhejiang INAR Medical Co., Ltd.

ISO 13485:2016

Quality Management System for Medical Devices issued by TÜV Rheinland.

Cert No: SX 2180356-1
MDSAP Certification DEKRA - Zhejiang INAR Medical Co., Ltd.

MDSAP Certified

Medical Device Single Audit Program certification issued by DEKRA for global markets.

Cert No: 6160843
CE Mark 93/42/EEC Directive - Zhejiang INAR Medical Co., Ltd.

CE Directive 93/42/EEC

CE Certification for orthopedic bone plates, screws, intramedullary nails, and PEEK cages.

Cert No: HD 2180356-1
EU MDR Regulation 2017/745 DEKRA - Zhejiang INAR Medical Co., Ltd.

EU MDR (2017/745)

EU Medical Device Regulation certificate for bone fixation plates issued by DEKRA.

Cert No: 6142788CE02
SGS Group Onsite Assessment - Zhejiang INAR Medical Co., Ltd.

SGS Onsite Verified

Onsite supplier capability verification performed and confirmed by SGS Group.

Report ID: 225224301
CE Sports Medicine Arthroscopy - Zhejiang INAR Medical Co., Ltd.

CE Sports Medicine

CE Certification for suture anchors, PLGA interference screws, and meniscus repair systems.

Cert No: 6050582CE01

Partner with Zhejiang INAR Medical Co., Ltd.

Request our complete product catalog, surgical technique manuals, and regulatory certificate dossiers to evaluate our manufacturing capabilities for your hospital tenders or distribution network.

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