ONE Mixed Pleasures Condom Set 12pcs - 6 Types
Condoms
Feature
Mix
Thickness
Mix
Texture
Mix
Form
Mix
Class
Premium
Brand
One
Lubricant
Mix
Size
Mix
Color
Mix
Smell
Mix
Manufacturer
Karex Industries Sdn Bhd
Country of Origin
Malaysia
Pieces per pack
12
Pieces per pack
12
Size, mm
Mix
Length, mm
Mix
Width, mm
Mix
Thickness, mm
Mix
Brand country
USA
Medical devices
Medical device
Medical device or in vitro diagnostic medical device
Medical device manufacturer
The Female Health Company (UK) Plc
Authorised representative
Advena Limited
EU CE marking
Yes
Notified body number
0123
Label and instructions in Polish
Yes
GPSR
Safety information
This is a medical device. Use in accordance with the instructions for use or labelling. Single-use product. Contains natural rubber latex, which may cause allergic reactions, including anaphylactic shock in latex-sensitive individuals.
Product warnings
Warnings: Store in a cool, dry place, away from direct sunlight. Do not use after the expiry date. No method of contraception provides 100% protection against pregnancy, HIV or sexually transmitted infections. Single-use product — do not reuse. Do not use if the foil packaging is damaged. Dispose of used condoms in a bin, not down the toilet.
Responsible manufacturer
Karex Industries Sdn. Bhd.
Responsible manufacturer – street
PTD 7906 & 7907, Taman Pontian Jaya, Batu 34, Jalan Johor
Responsible manufacturer – postal code
82000
Responsible manufacturer – city
Pontian
Responsible manufacturer – country code
MY
Responsible manufacturer – e-mail
khairunnisa.w@karex.com.my
Responsible person in the EU
Advena Limited
Responsible person in the EU – street
Tower Street, Tower Business Centre, 2nd Flr.
Responsible person in the EU – postal code
BKR4013
Responsible person in the EU – city
Swatar
Responsible person in the EU – country code
MT
Responsible person in the EU – e-mail
prcv@advena.mt
Manufacturer contact details
PTD 7906 & 7907, Taman Pontian Jaya, Batu 34, Jalan Johor, Pontian, Johor 82000, MY
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Product Safety and Regulatory Compliance – ONE Condoms
General Safety and Usage Information (GPSR)
This product is a medical device. Use it according to the instructions provided on the packaging.
-
Storage: Store in a cool, dry place and protect from heat and direct sunlight. -
Package Integrity: Do not use if the individual packaging is damaged, opened or shows signs of deterioration. -
Single Use: Product for single use only. Dispose of used condoms in household waste. Do not flush in the toilet. -
Expiry: Do not use after the date printed on the outer packaging or individual foil. -
Instructions: Carefully read the instructions before use. - Protection Notice: No contraceptive can provide 100% protection against pregnancy, HIV or other sexually transmitted infections (STIs).
- Additional Lubricants: If additional lubricant is used, ensure it is compatible with latex condoms. Avoid oil-based lubricants.
Material Information
ONE condoms are made from natural rubber latex. Do not use if you have a known or suspected allergy to latex.
Medical Device Certification
CE Marking – compliant with EU medical device regulations.
Notified Body: 0123 – TÜV SÜD Product Service GmbH
Ridlerstraße 65, 80339 München, Germany
Website: www.de.tuv.com | Email: medical-products@de.tuv.com
Responsible Economic Operators
Manufacturer:
Karex Industries Sdn. Bhd. (MY-MF-000001247)
PTD 7906 & 7907, Taman Pontian Jaya, Batu 34, Jalan Johor,
82000 Pontian, Johor, Malaysia
Website: www.karex.com.my | Email: khairunnisa.w@karex.com.my
EU Authorized Representative:
Advena Limited (MT-AR-000000234)
Tower Business Centre, 2nd Floor, Tower Street,
Swatar BKR 4013, Malta
Website: www.advena.mt | Email: prrc@advena.mt
Importer:
Advena Services Ltd (MT-IM-000029828)
Tower Business Centre, Tower Street,
Swatar, BKR 4013, Malta
Email: importer@advena.mt
* Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety.