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Product Certification PDF

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0% found this document useful (0 votes)
228 views5 pages

Product Certification PDF

Uploaded by

Sico Laben
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
CERTIFICATE Management System as per ISO 14001 : 2004 In accordance with TOV NORD Indonesia procedures, itis hereby certified that PT. MEGA ANDALAN KALASAN Ji. Tanjungtirto No. 34, Kalasan Km 13, Sleman, Yogyakarta 55571 INDONESIA apples a management system in ine with the above standard forthe following scope Service of Pre Treatment (Waste Water Treatment) and Painting Process of Hospital Equipment Certificate Registration No. 08 104 0021 Valid uni 2017-09-18 ‘Audit Report No 1021/2014 Initial Certification 2008-08-10 TOV ORD Indonesia Certification Body Jakarta, 2014-08-19 TOV NORD Group ‘This certification was conducted in accordance with the TOV NORD Indonesia auditing and certfiation procedures and is subject to regular surveilance audits. PT TOVNORD lndonesa, Perantoran Hijau Arad Tower F 7" foo, J. Let Jend.T-8 Smatupang Kav. 8, Jakarta Selatan 12520 142616 CERTIFICATE Management System as per OHSAS 18001 : 2007 {In accordance with TOV NORD Indonesia procedures, itis hereby certified that PT. MEGA ANDALAN KALASAN Jl. Tanjungtirto No. 34, Kalasan Km 13, Sleman, Yogyakarta 55571 INDONESIA ‘applies a management system in ine with the above standard for the following Scope Service of Pre Treatment (Waste Water Treatment) and Painting Process of Hospital Equipment Certificate Registration No. 05104 2008 0087 ES Valid unt 2017-09-18 ‘Audit Report No. 011408410 Initial Certification 2008-09-10 RD Indonesia Certification Body Jakarta, 2014-09-49 NORD Group ‘This cortfiation was conducted in accordance with the TOV NORD Indonesia ausiting and certification procedures and is subject to regular surveillance audits. PT TOVNORD indonesia, Prkantoran Hau Aradia Tower F 7" foo, J. Let Jend 7.8 Smatupang Kav. 8 Jakarta Selatan 12520 Re wresre 8 142618 CERTIFICATE nie Management System as per ISO 9001 : 2008 = In accordance wth TOV NORD Indonesia procedures its PT. Mega Andalan Kalasan Office : Rasuna Office Park SO-02, | Ji. HR Rasuna Said, Jal Factory : Jl. Tanjung Tirto 34, Ti Yogyakarta, Indonesia ‘apples @ management system in ine with the above standard forthe Design and Manufacturing of Hospital Beds, | Wheel Chairs, Infuse Stands, Medicine Cabinets, Trolleys, Overbed Tables, Children Beds, Operating Tables Certiicate Registration No, 18 00 L 12453 ‘Audit Report No. 1215372012 J’ NORD Indonesia Certification Body NORD Group erification was conducted in accordance with the TUV NORD Indonesia auditing Procedures and is subject to regular surveilance audits S TuV NORD Zertifikat / Certificate gem. / acc. EN ISO 13485:2012 Hiermit wird boscheinigt, dass dle Firma / This coriies, thatthe company PT. Mega Andalan Kalasan Office: Rasuna Office Park SO-02, Komp. Rasuna Epicentrum Jl. HR Rasuna Said, Jakarta 12960 Factory: JL. Tanjung Tirto 34, Tirtomartani Kalasan Km 13, Yogyakarta Indonesia in Qualitatsmanagementsystem nach der Nom EN ISO 13485;2012 /DIN EN ISO 13485:2012-06 - Medizinprodukte- Qualtatsmanagerienisysteme - Anforderungen fir reguiatorische Zwecke- eingeUhrt hal und autrechterhak Dieses Zerikat elt nicht den erforéerichen Nachweis zur Anbingung der CE-Kennzeichnung dar has established and maintains a quality management system that meets the requirements of EN ISO 13485:2012/ DIN EN ISO 13485:2012-06 - Medical devices - Qually management systems - Requirements for regulatory purposes. This cetfcate isnot an authorisation fo ax the CE mark. Goltungsbereich / Scope Design and Manufacturing of Hospital Beds, Stretchers, Baby Boxes, Wheel Chairs, Infuse Stands, Medicine Cabinets, Bedside Cabinets, Food Trolleys, Overbed Tables, Children Beds, Examination Tables and Operating Tables Reg-Nt | Rog-No, 44221 121679 ‘cig vantty Britt Nr / Report No, 3510 7086 von fom 2012-41-21 bis / unt 2018-11-20 y if yy Edition 1 Zestificierungsstele fUrAedizinorodukte Essen, 201241612 Certification body for medical devices TOVNORD CERT GmbH — LangemarckstraBe 20 45141 Essen [Link] modical@[Link] Benannte Stelle Kenn-Nr. 0044 / Notifed Body ID. No. 0044 WOM Abode durch Certificate of Cé-Registration ‘This is to certify that, in accordance with the Medical Device Directive 93/42/EEC, Medical Device Safely Service GmbH (MDSS) agrees to perform all duties and responsibilities as the Authorized Representative for: PT Mega Andalan Kalasan JI. Tanjung Tirto 34, Tirtomartani Kalasan KM 13 YOGYAKARTA, INDONESIA a stipulated and demanded by the aforementioned Directive. The German Competent Authority has allocated the medical devices of the Manufacturer registration numbers as foreseen in’ Annex A dated September 5, 2014 The Manufacturer hes provided MDSS with the appropriate Deciaration(s) of Conformity confirming that the medical devices fulfill the applicable requirements of Directive 93/42/EEC. In compliance with German law, a safely officer has been appointed for Germany. 2014-09-05 {oun (ula Warmemann jor Manager Registration MOSS GmbH IMDS - Medical Device Safety Service 5 ffgraben 41 » 30175 Hannover, Germany

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