FDA Registered Facility

Clinical-Grade Nasal Strips & Safety-Vent Mouth Tape

The OEM partner for medical distributors and clinical brands. We combine high-volume manufacturing with strict ISO 13485 compliance.

Production Standards

FDA ISO CE SGS
Medical Manufacturing
Daily Output
500K+
Units per shift
Quality Level
AQL 1.5 Medical
Vision inspection active

Dedicated Channels

We don't do dropshipping. We serve three distinct medical supply chains.

Warehouse

DME Distributors

For large-scale medical equipment suppliers.

  • Bulk Pallet Shipping
  • Low Cost-Per-Unit
  • Private Label Boxes
Clinic

Sleep & Dental Clinics

Designed for orthodontic and nasal support.

  • Patient Sample Kits
  • Hygiene Sealed Packs
  • Sensitive Skin Adhesives
Retail

Compliance Brands

For brands needing strict platform compliance.

  • MDR/TF Support
  • Amazon Safety Docs
  • Claims Review
Quality Control Process

Risk Removed

0% Rejection Rate

The 3 Procurement Risks We Eliminate

Safety & Liability

Cheap adhesives cause skin tears. We use exclusively medical-grade ISO 13485 acrylates to prevent customer injury claims.

Platform Compliance

Avoid Amazon "Product Safety" take-downs. Our mouth tapes feature mandatory mechanical vents to meet global anti-suffocation policies.

Supply Continuity

Don't let stockouts kill your ranking. We offer "Forecast Locking" to keep dedicated raw materials for your quarterly needs.

Future-Proof Medical Materials

PFAS-free, Latex-free, and REACH aligned options.

Non-Woven
Magnification 10x

Breathable Non-Woven

Standard porous structure.

Cotton
Organic Fiber

Pure Medical Cotton

Hypoallergenic & natural.

Silicone
Hydrogel Layer

Silicone Gel Adhesive

Pain-free removal.

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Clinical Product Systems

Validated shapes and tension levels for specific therapies.

Ortho-Vent System Blueprint

Ortho-Vent System

Dental

Extra-elasticity spring bands designed for patients wearing night guards.

Force: 15g (High) SKU: OVS-01
Myo-Frame System Blueprint

Myo-Frame System

Therapy

Lip-seal training tape with large central safety vent. Gel adhesive.

Force: Low Tack SKU: MFS-04
Pharmacy Standard Blueprint

Pharmacy Standard

Retail

Cost-optimized standard shape with balanced adhesion for volume sales.

Force: 12g (Std) SKU: PSS-09

Scalable Delivery Options

From clinic master cartons to retail-ready shelves.

Bulk

Clinical Bulk Packs

High-density packing (1000 strips/bag) for repackaging or clinic use. Minimized waste.

Retail

Retail-Ready Boxes

Full color printing, barcodes applied, and tamper-evident sealing. FBA ready.

DDP Shipping FBA Prep
Packaging Line

Automated Boxing Line

Capacity: 50,000 packs / day

Quality You Can Verify

Transparent manufacturing process.

Lab

1. Incoming QC

Bio-burden testing on all raw materials before they enter the clean room.

Vision

2. In-Process Vision

High-speed cameras detect debris or shape defects during die-cutting.

Testing

3. Adhesion Testing

Random sampling for 180-degree peel force verification per batch.

Coding

4. Lot Coding

Inkjet printing of Lot # and Exp Date for full traceability.

COA

5. Final COA

Certificate of Analysis generated and signed by Quality Manager.

Retention

6. Retention

Reference samples kept for the duration of the product shelf life.

Certified Nasal Strips Manufacturer
TECHNICAL FILE
REF: ISO-13485

Documentation Pack for Faster Approval

Speed up your vendor onboarding. We provide a comprehensive compliance packet ready for your regulatory team.

  • ISO 13485 Alignment
  • MSDS / Material Safety
  • Batch COA Templates
  • Labeling Guidance
Get FREE Documentation Checklist

Ready to validate fit, comfort, and compliance before scaling?

Support Specialist

Compliance Team

Have specific regulatory questions?

Contact Support →

Common Questions

What are the MOQs for channel programs?
Clinical bulk packs start as low as 500 units. Private label retail runs typically start at 5,000 units.
Is your mouth tape design Amazon compliant?
Yes. Our designs feature mandatory air vents/gaps to comply with anti-suffocation policies.
Do you offer DDP Shipping?
Yes, we can handle customs clearance and delivery duty paid to US and EU addresses.
Factory Direct • OEM/ODM

Scale Your Brand with
Medical-Grade Manufacturing.

Stop dealing with middlemen. Partner directly with an ISO 13485 certified factory for high-performance nasal strips and mouth tapes. We secure your supply chain with FDA-compliant production and DDP delivery.

Global Compliance

FDA Registered, CE (MDR), and ISO 13485 ready for EU & US markets.

Low MOQ Start

Launch private label pilots with just 500 units. Scale to 5M+ monthly.

Clean Room Manufacturing Facility

Facility Code: CN-ZRY-04

Request Quotation & Samples

Fill out the form below. Our engineering team typically responds with a preliminary quote within 24 hours.

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