PRODUCTS CERTIFICATION
Safety Certification Certified Mimos Pillow As A Very High Safety Standard Baby Products.
TEXTILE SAFETY CERTIFICATION – OEKOTEX 100 CLASS
Oekotex seal is a certification that guarantees the absence of harmful chemical in textiles. All materials that make up the pillow including the label and thread to sew the different parts are certified Oekotex 100 class 1 for babies, the strictest of all.
CE CERTIFICATION CLASS 1 MEDICAL DEVICE – EUROPEAN
CE Marking on product is a Manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environment protection legislation.
SAFETY CERTIFICATION CERTIFIED MIMOS PILLOW AS A VERY HIGH SAFETY STANDARD BABY PRODUCT
Mimos Pillow is a product recommended by more than 1000 pediatric doctors, physiotherapists, neurosurgeons and midwives internationally.
EUROPEAN SAFETY CERTIFICATION EN71-1:2005
“SAFE FOR CHILDREN 0-3 YEARS”
This safety standard is the same that applies to toys intended for children between 0 and 3 years. The test includes tensile tests, torsion, fall, impact, compression and absence of small parts that can cause choking.
ISO 13485
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
TUV RHEINLAND AIR-FLOW SAFETY – ANTI-SUFFOCATION TUV CERTIFICATION
Mimos Pillow has been tested and certified to have high air permeability (DIN EN ISO 9237) and therefore it does not pose a risk of asphyxia for babies of any age.
- Textile products, Baby Pillow
- Air permeability exceeds the strict requirement criteria
- Anti-Suffocation
CO2 REBREATHING SAFE
Tested in US lab and confirmed by medical experts. Given results of the carbon dioxide evaluation, Mimos Pillow does not pose a significant hazard for carbon dioxide rebreathing.
NEW H2O AIRFLOW TEST CONDUCTED BY BUREAU VERITAS CONSUMER PRODUCTS SERVICES UK LTD.
The minimum airflow requirement is 20.4 mm H2O, and Mimos Pillow passed the test in flying colours by significant margin, only 0.42 mm of H2O. Bureau Veritas is a global leader in Testing, Inspection and Certification (TIC), it is recognized and accredited by major national and international organizations.
We are GDPMD certified company by Medical Device Authority (MDA) under Ministry of Health, Malaysia.
As stipulated in the Medical Device Act 2012, establishment in Malaysia dealing with medical device must attain Good Distribution Practice for Medical Device (GDPMD) status to demonstrate its ability to meet the quality requirement and to maintain safety and performance of medical equipment and device throughout the supply-chain.
Maurice Zenith Trading is proud to be the first baby pillow distributor in Malaysia to havesuccessfully obtained the GDPMD certification by Med Cert Malaysia, a registered conformity assessment body with the Medical Device Authority Malaysia (MDA).
The GDPMD certifications underlines Maurice Zenith Trading’s dedication to quality and compliance to further strengthen capabilities and service offerings to our partners and customers.
