ULEX® Condom Certifications
TÜV Rheinland · CE 0197 · ISO 13485 · EN ISO 4074
EU Authorised Representative: LIFETONIX SAS (Strasbourg, France)
Regulatory classification: Class IIb Medical Device — EU Regulation 2017/745
Notified Body: SGS Belgium NV (CE 0197)
Independent Testing: TÜV Rheinland Group
CE 0197
Mandatory European standard
TÜV Rheinland
Voluntary premium certification
ISO 13485
Medical device quality management
What is CE 0197 Certification?
CE 0197 is the mandatory European standard for condoms. The number 0197 refers to the notified body that certifies compliance. This certification ensures that condoms meet minimum safety requirements for strength, dimensions, and freedom from holes.
- Mandatory for all condoms sold in the European Economic Area
- Tests include: air burst test, water leak test, dimensions, packaging integrity
- Batch testing required — samples from each production lot
- Must comply with EN ISO 4074 standard
TÜV Rheinland Certification — Beyond CE Requirements
TÜV Rheinland is a voluntary premium certification that goes significantly beyond CE requirements. While CE testing is done on batch samples, TÜV Rheinland requires 100% electronic testing of every single condom.
What is Electronic Testing?
Every condom passes through an electronic conductivity test that detects microscopic pores, weak spots, and micro-tears invisible to the naked eye. This ensures zero defects — not just statistically acceptable quality.
ULEX® carries both CE 0197 and TÜV Rheinland certifications — placing it among the most rigorously tested condom brands available in Europe. This dual-certification approach reflects the brand's commitment to exceeding regulatory minimums.
ISO 13485 — Medical Device Quality Management
ISO 13485 is the international standard for quality management systems specific to medical devices. This certification ensures that every aspect of our manufacturing, from raw material sourcing to final packaging, follows rigorous quality control procedures.
- Documented quality management system
- Risk management throughout product lifecycle
- Traceability of all materials and components
- Regular audits and continuous improvement
- Complaint handling and corrective action procedures
EN ISO 4074 — Natural Latex Rubber Condom Standard
EN ISO 4074 is the specific technical standard for natural latex rubber condoms. It defines requirements and test methods for:
Dimensions
- • Length ≥ 160mm
- • Width 49–56mm (Regular)
- • Width 56–60mm (XL)
Strength Tests
- • Air burst pressure ≥ 1.0 kPa
- • Air burst volume ≥ 16L
- • Water leak test: 300ml, no leaks
Packaging
- • Individual sealed packaging
- • Expiration date clearly marked
- • Storage instructions included
Labeling
- • CE mark visible
- • Batch number traceable
- • Manufacturer information
How to Verify ULEX® Certifications
TÜV Rheinland Certificate: Verifiable at tuv.com/certificate-search — search for LIFETONIX SAS or ULEX® condoms.
CE 0197 (SGS Belgium NV): The "CE" mark with "0197" on all ULEX® packaging confirms assessment by Notified Body SGS Belgium NV under EU Regulation 2017/745.
ISO 13485: Quality management certificate issued annually. Covers design, manufacturing, testing, packaging, and post-market surveillance.
EN ISO 4074: Full compliance certified. Testing conducted per ISO 4074:2015 (Natural rubber latex male condoms — requirements and test methods).
Related Certification Guides
ULEX® Quality Summary
Our Certifications
- ✅ CE 0197 Certified
- ✅ TÜV Rheinland Tested
- ✅ ISO 13485 Compliant
- ✅ EN ISO 4074 Tested
- ✅ 100% Electronically Tested
What This Means for You
- ✅ Maximum safety and reliability
- ✅ Zero defects guaranteed
- ✅ European quality standards
- ✅ Full traceability
- ✅ Premium protection