Product: Mascherina chirurgica Tipo IIR
Model: Z-UNI-1803-ZM
Manufacturer: ZM Design. srl
Address of Manufacturer: Via Gianni Cozzi1, Santo Stefano al Mare, (IM)
Year: 2020
The manufacturer declares under his own responsibility that the medical device designated above complies with the essential requirements UNI EN ISO 14683, UNI EN ISO 10993 and of the following European Union directive:
Directive:
MDD 93/42/CE of June 14, 1993 amended by directive 2007/47/CE and subsequent amendments
The manufacturer agrees to keep the technical documentation available to the competent authorities at its headquarters, as per Annex VII of the aforementioned directive, for a period of 5 years (five) from the placing on the market of this class I medical device and declares that:
The Product “Mascherina chirurgica Tipo IIR Modello: Z-UNI-1803-ZM” has to be considered as a “Medical Device intended for the prevention of a disease” belonging to Class I.
The manufacturer has established a systematic procedure to evaluate the experience acquired in the use of the device in the post-production phase, as well as to maintain an appropriate system to be used to apply any corrective measures that may be necessary
Place: Santo Stefano al mare (IM), Italy
Legal representative
Giuseppe Zaoli
