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Both | Manufacturer

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작성자 CnA 작성일20-08-01 23:13 조회5,500회 댓글3건

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Indicates the medical device manufacturer, as defined in EU Directives 90/385/ EEC, 93/42/EEC and 98/79/EC

Requirements
This symbol shall be accompanied by the name and address of the manufacturer (i e the person placing the medical device on the market), adjacent to the symbol.

Informative notes
NOTE 1 This symbol is used to indicate information that is required in Europe b
NOTE 2 The full definition of "manufacturer" is given in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC
NOTE 3 Guidance on the requirements for EU Directives 90/385/EEC and 93/42/EEC is given in EN 1041
NOTE 4 Guidance on the requirements for EU Directive 98/79/EC is given in ISO 18113-1, ISO 18113-2, ISO 18113-3,
ISO 18113-4 and ISO 18113-5
NOTE 5 The date of manufacture, as well as the name and address of the manufacturer, can be combined in one symbol.
NOTE 6 The relative size of the symbol and the size of the name and address are not specified.

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