Quality
Quality, Standards & Labelling
Every PAMITEX condom is a CE-marked Class IIb medical device, electronically tested and traceable from the sealed foil to the shipping carton.
Standards
Built on the standards that matter
PAMITEX products are supplied against the European regulatory framework for medical devices. On this page, compliance is not a slogan: it is the specification we supply against.
EN ISO 4074
The harmonised standard for natural rubber latex condoms, covering dimensions, bursting volume and pressure, and freedom from holes.
MDR (EU) 2017/745
CE-marked Class IIb medical devices, manufactured under a certified quality management system.
CE 0123
The CE marking with the Notified Body number, printed on every professional pack.
Electronically tested
Every single condom is electronically tested for pinholes before it is sealed in its foil.
Packaging
Three levels of packaging, one traceable chain
From the single condom to the shipping carton, each level nests inside the next, so you always know exactly what you are buying, and how much.
The sealed unit
One sealed condom. Each unit is sealed in an aluminium barrier foil that protects it from light, air and humidity until the moment of use.
1 condom · sealed foilThe professional box
One box holds 144 condoms: this is the unit you order. It carries the full labelling, the instructions for use and batch traceability. Inside, the 144 can be supplied as loose foils or as retail multipacks (3, 6, 12 or 24) under your own brand, as a private label option.
144 condoms per boxThe master carton
Boxes are grouped into a standardised master carton for predictable palletising and transport. Logistics configurations and supply terms are available to qualified B2B partners.
Available to qualified B2B partnersLabelling
What every PAMITEX condom pack tells you
A compliant label is a promise of traceability. Here is what each PAMITEX condom pack carries, and why it matters. The personal lubricant is a different device and carries its own storage conditions.
- CE 0123
- The CE marking with the Notified Body number: the device conforms to MDR (EU) 2017/745.
- EN ISO 4074
- Conformity with the harmonised standard for natural rubber latex condoms.
- Medical device
- A regulated medical device, not a novelty item.
- Natural rubber latex
- Material declaration and an allergy warning for latex-sensitive users.
- LOT / batch number
- Batch-level identification for full traceability and recall capability.
- Manufacturing & expiry dates
- Shelf-life control, so no expired product reaches the shelf.
- Unique Device Identifier (UDI)
- Machine-readable traceability under MDR.
- Single use
- The do-not-reuse symbol: each condom is used once.
- Consult instructions for use
- Every pack refers the user to the complete instructions.
- Storage 0–25 °C · keep dry · away from sunlight
- The conditions that preserve the product’s integrity.
Instructions for use, in the pack and in five languages
Every professional box carries complete instructions for use in English, Italian, French, German and Spanish. The essentials:
- Single use only: a new condom for every encounter.
- Check the expiry date and open the foil carefully.
- Use only water-based, latex-compatible lubricants; never oil-based products.
- Store in a cool, dry place away from direct sunlight.
- Not to be used by people allergic to natural rubber latex: it may cause allergic reactions including anaphylactic shock. Consult a doctor or a pharmacist about the risk before use, and seek medical advice if a reaction occurs.
No method of prevention can guarantee absolute protection.
Traceability and vigilance
As the EU importer, PAMITEX GROUP Kft. maintains batch-level traceability and handles post-market feedback, forwarding relevant information through the regulatory chain. Quality does not end at delivery.
Product quality & vigilance →Compliance for qualified partners
Qualified B2B projects are reviewed individually.