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Conformity Certificate

Conformity Certificate

Product catalog summary
Conformity Certificate Overview
This document is a conformity certificate issued voluntarily by the manufacturer for specific products. It confirms the availability of a declaration of conformity prepared by the manufacturer, who is responsible for ensuring all necessary conformity assessment activities are completed according to the 2001/95/EC General Product Safety Directive and related standards before market placement.

Product Details
  • Product(s)/Trade marks: Hospital and Ward Furniture / TRINODAL
  • Product Types: Electronic and Manual Hospital Beds, Chairs, Accessories, Delivery Beds, Gynecologic & Obstetric Chairs, Ward Furniture, Trolleys, Overbed Tables, Bedside Cabinets, Stretchers, Hospital Bed Spare Parts

Standards and Directives
  • Applied Standard: EN 60601-2-52:2010 Medical Electrical Equipments - General Requirements for Safety
  • Applied Directive: 93/42/EEC Medical Device Directive

Compliance and Responsibility
The technical file and inspection results confirm compliance with the EN 60601-2-52:2010 standard. The manufacturer, POLYMETAL KALIP PLASTİK SANAYİ VE TİCARET LTD. ŞTİ., is responsible for maintaining a full technical file as per Annex VII of 2001/95/EC and taking all necessary actions before market placement. This certificate does not authorize the addition of the Conformité Européene mark to the product label.

Issuer Information
  • Issued by: INSPECT CERTIFICATIONS USA LLC, Wyoming, U.S.A
  • Issue Date: 24.09.2025
  • Validity: Until 23.09.2026
  • Certificate No: 25.08.303-CE

Manufacturer Information
  • Manufacturer: POLYMETAL KALIP PLASTİK SANAYİ VE TİCARET LTD. ŞTİ.
  • Address: ATATÜRK OSB 10002 SOKAK NO:44 ÇİĞLİ/İZMİR/TÜRKİYE
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Catalog excerpts

Conformity Certificate-1

Conformity Certificate Appl cant name and address POLYMETAL KALIP PLASTİK SANAYİ VE TİCARET LTD. ŞTİ. ATATÜRK OSB 10002 SOKAK NO:44 ÇİĞLİ/İZMİR/TÜRKİYE Manufacturer name and address POLYMETAL KALIP PLASTİK SANAYİ VE TİCARET LTD. ŞTİ. ATATÜRK OSB 10002 SOKAK NO:44 ÇİĞLİ/İZMİR/TÜRKİYE Product(s)/Trade marks Hospital and Ward Furniture / TRINODAL Product(s) TYPE(S) ELECTRONIC HOSPITAL BEDS, CHAIRS AND ACCESSORIES MANUAL HOSPITAL BEDS, CHAIRS AND ACCESSORIES DELIVERY BEDS, GYNECOLOGIC & OBSTETRIC CHAIRS WARD FURNITURE AND TROLLEYS OVERBED TABLES, BEDSIDE CABINET, STRETCHERS, HOSPITAL BED SPARE PARTS Appl ed standard(s) EN 60601 - 2 52:2010 Medical Electrical Equipments: General Requirements for Safety The technical file and inspection results of the above product have been checked and found in compliance with the EN 60601-2-52:2010 standard This paper shows that this product has conformity with the related standard Appl ed D rect ve(s) 93/42/EEC MEDICAL DEVICE DIRECTIVE Issue date: 24.09.2025 Validity of this certificate: 23.09.2026 Certificate No: 25.08.303-CE C General Manager This certificate has been issued according to the voluntary application of the manufacturer. This certificate is valid only for the product(s) in above mentioned. This certificate confirms that the decleration of conformity which is prepared by manufacturer is available. It's manufacturer's sole responsibility to meet all the neccessary conformity assessment activities according to 2001/95/EC General Product Safety Directive and related standards or the mentioned product(s) before placing them on the market. It is the manucturer's responsibility to comply a full technical file according to Annex VII of 2001/95/EC and the manufacturer is the responsible to take all necessary actions before placing them on the market. This certificate doesn't mean that The Conformité Européene mark can be added to the label above mentioned products. INSPECT CERTIFICATIONS USA LLC WYOMING 8280

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