SGS onsite-verified orthopedic manufacturer · CE (MDR / 93/42/EEC) implants · OEM & ODM
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Zhejiang INAR Medical Co., Ltd.

Company Profile

SGS-verified custom manufacturer of CE-marked orthopedic implants & surgical instruments for global hospital procurement.

Corporate Background

Leading Orthopedic Implant & Instrument Manufacturer

Zhejiang INAR Medical Co., Ltd. is a high-tech medical device manufacturer specializing in the design, CNC precision machining, surface finishing, and aseptic packaging of orthopedic trauma, spinal, and sports medicine implants.

Located in Jinhua, Zhejiang, China, our 29,523 m² manufacturing park houses state-of-the-art longitudinal cutting lathes, multi-axis CNC machining centers, anodizing lines, an ISO Class 7 aseptic packing room, and an in-house mechanical testing lab. Verified onsite by SGS Group, we serve global medical distributors and hospital networks with traceable quality control and regulatory export files.

SGS Onsite Audited
CE MDR & ISO 13485
MDSAP Certified
Zhejiang INAR Medical Co., Ltd. headquarter plant
Precision CNC machining floor
Clean manufacturing workshop
22+Years OEM/ODM
Mastery
22+
Years Experience
Dedicated to orthopedic manufacturing
29,523m²
Plant Area
Onsite audited production base
632
Total Staff
412 line operators & tech staff
59
R&D Engineers
20+ new product developments/yr
69
QC Specialists
100% batch penetrant & OQC inspection
97.0%
On-Time Dispatch
Outperforming category benchmark
44.4%
Reorder Rate
Trusted by global distributors
4.6/5
Buyer Score
Verified customer satisfaction
Enterprise Strength

Integrated Factory Infrastructure

Zhejiang INAR Medical Co., Ltd. handles raw material cutting, micro-machining, electro-polishing, color anodizing, quality control, and sterile packaging completely in-house.

Precision Manufacturing

Equipped with high-precision longitudinal cutting lathes and multi-axis CNC machines optimized for titanium alloy (TC4 / Grade 5) and medical-grade PEEK polymer.

  • Longitudinal cutting lathes & Swiss-type CNCs
  • Ultrasonic multi-stage washing systems
  • Automatic titanium color anodizing plant

Rigorous Quality Control

Every single batch undergoes dimensional inspection, fluorescent penetrant testing for structural micro-cracks, surface finish analysis, and final OQC before clearance.

  • 69 full-time QA/QC inspectors
  • Dedicated fluorescent penetrant testing darkroom
  • Biocompatibility & packaging aging verification

Cleanroom & Packaging

Controlled aseptic packaging room for sterile and non-sterile implant kit assembly, ensuring compliance with international sterile barrier standards.

  • ISO Class 7 aseptic packing room
  • Custom laser marking & UDI barcode tagging
  • Export-grade protective transport packaging
Traceable Production

Implant & Instrument Production Workflow

A transparent, standardized manufacturing route ensures complete batch traceability from raw bar stock to finished sterile products.

Step 01 Raw Material Inspection - Zhejiang INAR Medical Co., Ltd.

Raw Material Verification

Step 02 Longitudinal Cutting - Zhejiang INAR Medical Co., Ltd.

Longitudinal Cutting

Step 03 Precision CNC Machining - Zhejiang INAR Medical Co., Ltd.

CNC Machining

Step 04 Polishing Stage - Zhejiang INAR Medical Co., Ltd.

Precision Polishing

Step 05 Ultrasonic Washing - Zhejiang INAR Medical Co., Ltd.

Ultrasonic Washing I

Step 06 Grinding Process - Zhejiang INAR Medical Co., Ltd.

Micro Grinding

Step 07 Sand Blasting - Zhejiang INAR Medical Co., Ltd.

Sand-Blasting Treatment

Step 08 Penetrant Testing - Zhejiang INAR Medical Co., Ltd.

Penetrant Micro-Defect Test

Step 09 Anodizing - Zhejiang INAR Medical Co., Ltd.

Anodizing Color Coding

Step 10 Ultrasonic Washing Stage 2 - Zhejiang INAR Medical Co., Ltd.

Ultrasonic Washing II

Step 11 Outgoing Quality Control - Zhejiang INAR Medical Co., Ltd.

Outgoing Quality Control (OQC)

Step 12 Aseptic Packing Room - Zhejiang INAR Medical Co., Ltd.

Aseptic Room Packaging

Testing & Reliability

In-House Quality Testing Laboratory

Our testing lab conducts mechanical, structural fatigue, and accelerated aging evaluations to ensure total implant reliability in clinical environments.

Penetrant Testing Room - Zhejiang INAR Medical Co., Ltd.

Penetrant Testing Room

Dedicated darkroom equipped with high-sensitivity fluorescent dye penetrants to inspect surface cracks, voids, and flaws under UV light.

Implant Endurance Tester - Zhejiang INAR Medical Co., Ltd.

Endurance Fatigue Tester

Dynamic mechanical testing systems simulating cyclic biomechanical stresses on bone plates, pedicle screws, and interbody cages according to ASTM/ISO standards.

Accelerated Aging Tester - Zhejiang INAR Medical Co., Ltd.

Packaging Aging Tester

Accelerated thermal and environmental aging chambers evaluating long-term sterile barrier integrity and material shelf-life performance.

Global Approvals

Certifications & Regulatory Compliance

Zhejiang INAR Medical Co., Ltd. holds comprehensive international quality certifications, enabling seamless registration for global importers.

CE MDR Certification DEKRA Issued

EU MDR (2017/745)

Certified under European Union Medical Device Regulation for bone fixation plates and orthopedic trauma implants.

Directive 93/42/EEC Certification TÜV Rheinland

CE Directive 93/42/EEC

Compliance certification covering intramedullary nail systems, spinal pedicle screw systems, PEEK cages, and suture anchors.

SGS Onsite Supplier Assessment SGS Verified

ISO 13485 & MDSAP

Certified Quality Management System for design, production, and supply of implants across North America, Europe, and Asia-Pacific.

Partner with Zhejiang INAR Medical Co., Ltd.

Request our comprehensive product catalog, ISO/CE compliance dossier, or OEM/ODM custom manufacturing proposal today. Our export team responds within 4 hours.

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