• 📍 Factory Address

    Unit 1, No. 9 Shangheng Road, Chang'an Town, Dongguan, Guangdong, China 523850

  • 📧 Get In Touch

    Email: info@oqpox.com
    WhatsApp: +86 139 2582 8832
    Response within 24 hours guaranteed

  • 🕐 Business Hours

    Monday – Friday: 9:00 AM – 6:00 PM (GMT+8)
    Saturday: 9:00 AM – 12:00 PM
    Sample requests processed within 1 business day

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Contact Our OEM/ODM Team

Whether you're ready to start a custom project or just exploring options — our team responds to every inquiry within 24 hours.

Quality Assurance & Global Compliance

FDA Registered · CE Certified · ISO 9001 · RoHS Compliant

We provide full compliance support for electric toothbrush and water flosser OEM/ODM projects targeting US, EU, and global markets.

Download Compliance Package

Certifications at a Glance

Our facility maintains active certifications across all major global markets, ensuring your products meet regulatory requirements from day one.

🌍 Global

ISO 9001:2025

Certified since 2015, regular audits

ISO 20127:2025

Electric toothbrush performance

🇺🇸 North America

FDA Registration

Class I/II, 510k available

FCC & UL

EMC tested, UL report

🇪🇺 EU

CE LVD+EMC

EN 60335-2-52, EN 55014-1/2

RoHS & REACH

Hazardous substances

UKCA

UK market

Note: All electric toothbrushes and water flossers containing batteries comply with UN 38.3 and MSDS for safe transportation.

Quality Management System

1
IQC
Incoming materials
2
IPQC
In-process
3
FQC
100% function test
4
OQC
Outgoing sampling
100%
Function Tested
<0.5%
Return Rate
2015
ISO 9001 Since

Product-Level Compliance

Product Category Applicable Standards & Certifications
Electric Toothbrushes FDA, CE (LVD+EMC), RoHS, FCC, ISO 20127, IPX7, REACH, Battery UN38.3
Water Flossers FDA, CE (LVD+EMC), RoHS, FCC, IPX7, REACH, Battery UN38.3, Pressure Safety
Replacement Brush Heads/Nozzles FDA Food Contact, REACH, RoHS, MSDS
Compliance Consulting: Our team can guide you through market-specific requirements and provide documentation support for your target regions.

Testing & Laboratory Capabilities

⚡

Electrical Safety

Voltage, current, insulation resistance

📡

EMC Testing

Emissions, immunity, harmonics

🧪

Material Compliance

RoHS, REACH, phthalates

💧

IPX7 Waterproof

Submersion testing, seal integrity

🔋

Battery Safety

UN 38.3, overcharge, short circuit

🔨

Mechanical Durability

Drop test, vibration, life cycle

Third-Party Labs: We work with SGS, TÜV, and Intertek accredited laboratories for independent verification.

Documentation & Traceability

📋

Product Technical File

Complete design dossier

📊

Test Reports

All compliance testing

🏆

Certificates

ISO, FDA, CE, FCC

✍️

Declaration of Conformity

EU DoC, UKCA DoC

🔍

Batch Traceability

Full supply chain records

📖

User Manual & Labeling

Multi-language, compliant

Frequently Asked Questions

What is your quality control process?
We implement a four-stage QC system: IQC (incoming materials inspection), IPQC (in-process quality control), FQC (100% function testing), and OQC (outgoing quality control with AQL sampling). Every unit is tested before shipment.
Are you FDA registered?
Yes, our facility is FDA registered and we manufacture Class I and Class II medical devices. We can provide 510(k) support for products requiring premarket notification.
Which CE directives do you comply with?
We comply with CE LVD (Low Voltage Directive), EMC (Electromagnetic Compatibility), RoHS (Restriction of Hazardous Substances), and REACH (chemical safety). All products include CE marking and Declaration of Conformity.
Can you provide test reports from third-party labs?
Yes, we work with SGS, TÜV, and Intertek for independent testing and certification. Test reports are available under NDA for qualified customers.
What happens if a product fails quality inspection?
We follow a CAPA (Corrective and Preventive Action) process. Failed units are quarantined, root cause analysis is performed, and corrective measures are implemented. Typical resolution time is 7-14 days.
How do you ensure supply chain traceability?
All raw materials are sourced from ISO-certified suppliers with full COA (Certificate of Analysis) records. Each production batch is assigned a unique lot number with complete traceability from components to finished goods.