📞 +86-159-5839-0525 (24/7 Clinical & OEM Desk) ✉️ regulatory@mednova-medical.com 📍 BioBay Medical Industrial Park, Suzhou, China
ISO 13485:2016 CE MDR 2017/745 FDA 510(k) K231849 GMP Class 100,000
🩺 AeroTrade T3 · BioPure Medical Architecture • ISO 13485:2016 & CE MDR 2017/745 Certified

Precision Minimally Invasive Surgical & ICU Monitoring Systems

Engineered specifically for life-science and medical device exporters. MedNova delivers complete MDR technical files, EO sterilization batch certificates, and OEM private-label packaging for global hospital distributors and Ministry of Health tenders.

Explore 510(k) Catalog →
18,000 m² Class 100,000 Cleanroom
46+ CE MDR & FDA Registrations
92 Countries Ministry of Health Tenders
99.94% EO Sterility Pass Rate
MedNova Modular ICU Patient Monitor and Minimally Invasive Surgical Suite
🛡️
TÜV SÜD Audited Facility Cert No. Q5 098421 0012 Rev.03
Product Categories

Clinical Divisions Engineered for Tender Compliance

Every product family ships with Certificate of Free Sale (CFS), ISO 10993 biocompatibility reports, and multi-language IFU manuals.

CE Class IIb Minimally Invasive Endoscopic Staplers

Endoscopic Surgical Staplers

Powered articulating linear cutter staplers, circular hemorrhoidal staplers, and titanium reload cartridges.

View 18 SKUs →
FDA 510(k) ICU Patient Monitors & Anesthesia Workstations

ICU & OR Life Support

Multi-parameter patient monitors, video laryngoscopes, syringe infusion pumps, and central nursing stations.

View 24 SKUs →
CE Class III Cardiovascular & Hernia Repair Biosurgery

Biosurgery & Hernia Mesh

Lightweight polypropylene composite hernia patches, absorbable PGA sutures, and hemostatic gauze.

View 15 SKUs →
ISO 13485 IVD Lab Consumables & Cryogenic Vials

IVD Lab Consumables

DNase/RNase-free robotic pipette tips, PCR 96-well plates, and medical-grade virgin PP centrifuge tubes.

View 32 SKUs →
Cleared Devices & Best Selling

Hospital-Ready Devices with Transparent FOB Tiers

Switch currencies in the top bar (USD / EUR / GBP) or click any SKU for an instant pre-filled regulatory quote.

FDA 510(k) / CE IIb MN-V800 15.6-Inch Modular ICU Patient Monitor
SKU: MN-V800-ICU

MN-V800 15.6" Modular Touch ICU Patient Monitor (ECG/SpO2/IBP/EtCO2)

  • MOQ: 5 Units
  • Sterilization / IP: IPX1 Waterproof
  • Lead Time: 7–10 Days (FOB Shanghai)
$680.00 / Unit
CE MDR Class IIb Powered Endoscopic Linear Cutter Stapler
SKU: MN-ENDO-60P

Powered Articulating Endoscopic Linear Cutter Stapler (60mm Tri-Staple)

  • MOQ: 50 Pieces
  • Sterilization: EO Gas Sterile (5-Yr Shelf)
  • Lead Time: 12 Days (FOB Shanghai)
$42.50 / Pc
CE Class III Implant 3D Anatomical Lightweight Polypropylene Hernia Mesh
SKU: MN-MESH-1510

3D Macro-Porous Lightweight Polypropylene Inguinal Hernia Repair Mesh (10×15cm)

  • MOQ: 100 Boxes
  • Material: Monofilament PP (38 g/m²)
  • Lead Time: 10 Days (FOB Shanghai)
$18.80 / Box
CE / FDA Cleared Dual-Channel Touchscreen Syringe Infusion Pump
SKU: MN-SP200-DUAL

MN-SP200 Dual-Channel Stackable ICU Syringe Infusion Pump with Drug Library

  • MOQ: 10 Units
  • Accuracy: ±1.8% Flow Precision
  • Lead Time: 7 Days (FOB Shanghai)
$310.00 / Unit
MedNova Class 100,000 ISO 13485 Cleanroom Manufacturing Facility
About Suzhou MedNova Medical

Audit-Ready Class 100,000 Cleanroom & In-House EO Sterilization

Operating out of BioBay Medical Industrial Park in Suzhou, MedNova maintains full vertical integration from precision CNC titanium staple forming and cleanroom injection molding to ISO 11135 validated Ethylene Oxide (EO) sterilization and biological indicator batch release.

  • ✅ 18,000 m² ISO Class 8 Cleanroom
  • ✅ In-House EO Sterilization Chambers
  • ✅ Full UDI Barcode & MDR Traceability
  • ✅ Bilingual Regulatory Dossier Support
← Back to AeroTrade Studio Hub
2025 MEDICA Düsseldorf Exhibitor

Need Custom OEM Sterile Blister Packaging for National Tenders?

We provide rapid 14-day OEM sample validation, custom Tyvek® blister sealing, and embassy legalization for Ministry of Health tenders across Latin America, MENA, and Europe.

"MedNova's MDR technical documentation passed our German Notified Body review on the first submission. Their powered endoscopic staplers have zero misfire incidents across 4,200+ bariatric procedures in Munich."

Dr. Lukas Weber — Chief Procurement Director Bavaria Surgical Supply GmbH (Germany)

"We won a 320-unit ICU monitor tender for public hospitals in São Paulo thanks to MedNova's ANVISA registration support and 8-day air-freight dispatch."

Carlos Mendoza — VP of Hospital Tenders VidaMed Equipamentos Hospitalares (Brazil)
Regulatory & Export FAQ

Frequently Asked Questions by Medical Distributors

Do you provide Certificate of Free Sale (CFS) and Embassy Legalization for MOH registration?
Yes. We provide NMPA Certificate of Free Sale (CFS), apostille certification, and embassy legalization for Brazil (ANVISA), Saudi Arabia (SFDA), Southeast Asia (HSA/MDA), and Latin American Ministries of Health within 10 working days.
What is your sterile shelf-life and batch release protocol?
All disposable surgical staplers and hernia meshes undergo validated Ethylene Oxide (EO) sterilization in compliance with ISO 11135, offering a validated 5-year shelf life. Every shipment includes biological indicator sterility reports and EO residual gas test certificates.
Can we customize the patient monitor UI language and startup hospital logo?
Absolutely. For orders of 20+ units, we pre-install your custom boot logo, localized firmware (Spanish, Portuguese, German, Russian, Arabic, French), and custom silk-screen front bezel branding at zero extra tooling fee.
🧬

ISO Class 8 Cleanroom

18,000 m² positive-pressure cleanroom with automated particle monitoring

📋

Complete MDR & 510(k) Files

Dedicated RA/QA engineers provide CFS, ISO 10993 & MOH tender dossiers

🧪

EO Sterility Batch Release

ISO 11135 validated sterilization with biological indicator test reports

🌐

Global Tender Protection

Exclusive regional distributor authorization & 24-month clinical warranty