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Certifications & Compliance
CE Marked · FDA Registered · RoHS Compliant · ISO 9001 Certified. Full documentation available for every OEM order.
Request Compliance Documents →Our Certifications
All certifications are active and regularly renewed. Documentation packages available upon request for qualified buyers.
CE Marked — European Conformity
Our products comply with EU Low Voltage Directive (LVD) and Electromagnetic Compatibility (EMC) requirements, granting full access to the European market.
- EN 60335-2-52 (Electric toothbrushes)
- EN 55014-1/2 (EMC emissions & immunity)
- Declaration of Conformity provided with every order
- UKCA equivalent available for UK market
FDA Registered — US Market Access
Our facility is registered with the US Food & Drug Administration for Class I and Class II medical device manufacturing.
- Class I / Class II device registration
- 510(k) premarket notification support available
- FDA registration number available upon request
- Suitable for US retail, Amazon, and dental distribution
RoHS Compliant — Hazardous Substances
All products comply with the EU Restriction of Hazardous Substances Directive, ensuring freedom from lead, mercury, cadmium, and other restricted materials.
- RoHS 2 (2011/65/EU) compliant
- REACH chemical safety compliance
- Material test reports available from accredited labs
- Required for EU, UK, and many global markets
ISO 9001:2015 — Quality Management
Our quality management system has been ISO 9001 certified since 2015, with regular third-party audits ensuring consistent manufacturing standards.
- Certified since 2015, regularly renewed
- Covers design, production, testing, and delivery
- 6-stage in-house QC process
- Third-party audit reports available upon request
Compliance by Product & Market
All certifications apply to our standard product range. Additional market-specific certifications available on request.
| Product | EU | US | Global |
|---|---|---|---|
| Electric Toothbrushes | CE Marked, RoHS, REACH | FDA Registered | ISO 9001, IPX7, UN38.3 |
| Water Flossers | CE Marked, RoHS, REACH | FDA Registered | ISO 9001, IPX7, UN38.3 |
| Ultrasonic Dental Cleaners | CE Marked, RoHS | FDA Registered | ISO 9001, IPX7 |
| Replacement Heads / Nozzles | RoHS, REACH | FDA Food Contact | MSDS available |
Documentation Available
We provide a complete compliance documentation package with every OEM order.
📋 Certificate Copies
Scanned copies of CE, FDA, RoHS, and ISO 9001 certificates. Available for qualified buyers after NDA signing.
📊 Test Reports
Third-party lab test reports from SGS, Bureau Veritas, or Intertek. Covers electrical safety, EMC, waterproof, and material compliance.
✍️ Declaration of Conformity
EU DoC and UKCA DoC for CE Marked products. Issued per product model, available in English and other languages.
🔍 MSDS & Material Reports
Material Safety Data Sheets and COA (Certificate of Analysis) for all raw materials. Required for air freight and hazmat compliance.
Frequently Asked Questions
Is OQPO CE certified for electric toothbrushes?
Yes. OQPO's electric toothbrushes are CE Marked under the EU Low Voltage Directive (LVD) and EMC Directive, complying with EN 60335-2-52 and EN 55014-1/2. A Declaration of Conformity is provided with every OEM order. UKCA certification for the UK market is also available.
Is OQPO FDA registered?
Yes. Our manufacturing facility in Dongguan, China is registered with the US Food & Drug Administration (FDA) for Class I and Class II medical device manufacturing. The FDA registration number is available upon request for qualified buyers.
What certifications does OQPO hold for OEM electric toothbrush manufacturing?
OQPO holds four core certifications: CE Marked (EU market access), FDA Registered (US market access), RoHS Compliant (hazardous substance restriction), and ISO 9001:2015 (quality management system). All certifications are active and regularly renewed.
Can OQPO provide compliance documents for my private label brand?
Yes. We provide a full compliance documentation package with every OEM order, including certificate copies, third-party test reports (SGS, Bureau Veritas, or Intertek), Declaration of Conformity, and MSDS. Documents are available after NDA signing. Contact us to request a documentation package.
Are OQPO products RoHS compliant?
Yes. All OQPO products comply with RoHS 2 Directive (2011/65/EU), restricting lead, mercury, cadmium, hexavalent chromium, and other hazardous substances. REACH chemical safety compliance is also maintained. Material test reports from accredited laboratories are available upon request.
How long has OQPO been ISO 9001 certified?
OQPO has maintained ISO 9001 certification since 2015. The quality management system covers design, production, testing, and delivery, with regular third-party audits. Our 6-stage in-house QC process ensures consistent manufacturing standards across all OEM orders.
Request Compliance Documents
Tell us your target market and product requirements. We will send the relevant certification package within 24 business hours.
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