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EU DECLARATION OF CONFORMITY
1 /2Pages

 EU DECLARATION OF CONFORMITY

EU DECLARATION OF CONFORMITY
1 /2Pages

Catalog excerpts

 EU DECLARATION OF CONFORMITY-1

Document Number : INTCO AH-CE-DC-SNBR-001 Authorized Representative Name: Anhui Intco Medical Products Address: No. 6, Haitang South Road, Suixi Wuhu Modern Industrial Park, Suixi County, Huaibei City, Anhui Province Address: Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands Declares that the MDR described hereafter Product name and model: SYNGUARD® Nitrile Exam GlovesEMDN code: T01020204 Model: XS /S /MIL /XL/XXL Product Code: SNV/B/H/PE (Please refer to the attachment for more details). This Declaration of Conformity is issued under the sole responsibility of the manufacturer: Anhui Intco Medical Products Co., Ltd. Classification: Class I for medical device(rule 1 & rule 5, Annex VIII MDR), Cat III for PPE (Annex II) We declare that the production of medical devices as specified above is carried out in accordance with MDR EU 2017/745 and PPE regulation EU 2016/425 The notified body SATRA Technology Europe Ltd (Number: 2777) performed: - EU type-examination Certificate (Module B), certificate number: 2777/14815-03/E00-00 We agree to develop, implement and maintain a documented post-productio: Place, date Anhui 2023-11-14 Legally binding signature, Function Quality

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