DISPOSABLE RESPIRATORY

Description

The medical device is also identifiable by the following means:
– The product picture
– Each medical device wears the name indicated on this declaration of conformity.
– Each medical device wears the bar code indicated in the annex to this declaration of conformity.
– Each medical device wears a batch number. Our organization, based on this batch number, allows us to
ensure the traceability of the medical device.
DECLARATION OF CONFORMITY
This declaration of conformity is issued under the sole responsibility of the manufacturer.
The object of the declaration identified above is in conformity with the relevant Union harmonization
legislation:
93/42/EEC Directive, with its requirements, its annex VII and with the harmonized standards:
DECLARATION OF CONFORMITY
DELTA PLUS GROUP- ZAC La Peyrolière – BP 140 – 84405 Apt cedex FRANCE – Tél :+33 (0)4 90 74 20 33 – Fax :+33 (0)4 90 74
32 59
E-mail : information@deltaplus.fr – Web : www.deltaplus.eu
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APT, the 9
th April 2020
93/42/EEC DIRECTIVE
EN14683:2019 – Medical face masks – Requirements and test methods
Type II – Bacterial Filtration Efficiency ≥ 98%
ISO 22609:2004 – Test method for resistance against penetration by synthetic blood
Resistance at 80mmHg
EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for
regulatory purposes