TÜV Rheinland and Condom Certification

The Certification Landscape

In the European Union, condoms are classified as Class IIb Medical Devices under EU Regulation 2017/745. This means:

• Mandatory CE marking (minimum standard)
• Assessment by a Notified Body (CE 0197 = SGS Belgium NV)
• Compliance with EN ISO 4074 (natural rubber latex male condoms)

CE 0197 is the minimum legal requirement. Every condom legally sold in the EU must carry it.

What Is TÜV Rheinland?

TÜV Rheinland is an independent German testing and certification organization, founded in 1872. Unlike CE marking (self-declaration with Notified Body review), TÜV Rheinland certification involves:

1. Factory audits — physical inspection of manufacturing facilities
2. Product testing — independent laboratory testing of production samples
3. Annual renewal — not a one-time certification
4. Public registry — verifiable on TÜV Rheinland's official database

Why Most Brands Don't Have It

TÜV certification is:

• Expensive: requires ongoing facility audits and laboratory fees
• Demanding: higher testing thresholds than CE minimum
• Voluntary: legally not required

ULEX® Premium Condoms: TÜV Certified

ULEX® pursued TÜV Rheinland certification because it aligns with the brand's intimate wellness philosophy: only the highest safety standards are acceptable for products used in intimate contexts.

ULEX® certification stack:

• ✅ TÜV Rheinland — voluntary premium certification
• ✅ CE 0197 — EU mandatory certification
• ✅ ISO 13485 — medical device quality management
• ✅ EN ISO 4074 — latex condom standard

Verifying ULEX® Certification

ULEX® TÜV certification can be verified at: tuv.com/certificate-search

Choose certified protection: ULEX® Premium Condoms — Europe's most certified consumer condom brand.