Product Safety & Regulatory Compliance

Our Commitment to Safety & Compliance

At Ceretone, we are committed to ensuring that all of our products meet the highest international standards for safety, quality, and performance.

Our hearing devices are manufactured in accordance with globally recognised medical device regulations and are supported by independent certification and regulatory clearance.

🇺🇸 FDA Clearance (United States)

Our devices are classified as self-fitting air-conduction hearing aids (Class II medical devices) and have received FDA 510(k) clearance.

  • 510(k) Number: K221052
  • Classification: Class II Medical Device
  • Regulation: 21 CFR 874.3325

This means the device has been reviewed and determined to be substantially equivalent to legally marketed devices and is permitted for commercial distribution in the United States.

See official FDA documentation here

🇪🇺 European Medical Device Compliance (CE Marking)

Our products comply with the European Medical Device Regulation (EU) 2017/745 (MDR).

  • Device classification: Class IIa
  • Intended use: Compensation for impaired hearing
  • Conformity assessment conducted by: SGS Belgium (Notified Body 1639)

This confirms that our devices meet strict EU requirements for safety, clinical performance, and risk

See official MDR documentation here

Quality Management & Manufacturing Standards

The manufacturer operates under a certified Quality Management System (QMS) in accordance with:

  • ISO 13485 (Medical Device Quality Standard)
  • MDR (EU) 2017/745 – Annex IX

Certification details:

  • Certificate: CN
    24/00005770
  • Valid until: 09 September 2029
  • Audited by: SGS Belgium

This ensures consistent product quality, traceability, and regulatory compliance throughout the manufacturing process.

See the official Declaration of Compatibility documentation here

Product Labelling & Compliance

All products:

  • Comply with applicable medical device regulations
  • They are manufactured under controlled and audited conditions
  • Include appropriate labelling, instructions, and safety information

Important Information

Our devices are designed for self-fitting use and do not require a prescription in certain markets. However, hearing loss can have multiple causes.

We recommend seeking professional medical advice if you:

  • Experience sudden hearing loss
  • Have pain, discharge, or dizziness
  • Are unsure about your hearing condition

Contact Us

If you require further regulatory documentation or certification details, please contact: customerservice@secondchance.co.uk