MASCHERINA CHIRURGICA

Mascherina Chirurgica ad altissimo potere filtrante per uso medicale.

Comoda ed adatta all’utilizzo prolungato la nostra Mascherina Chirurgica è realizzata con tre veli e strato interno filtrante in tessuto “non tessuto” meltblown, e garantisce una straordinaria efficacia di filtraggio ≥ al 98%. Ciascun cartone contiene 40 confezioni da 50 pezzi ciascuna.

CERTIFICAZIONI

→ Dispositivo Medico (MDD) di classificazione I - conforme alla direttiva 93/42/ECC MDD Annex VII

→ Conforme EN 14683:2019+AC:2019 “Medical face masks - Requirements and test methods”

→ Certificato di Conformità CE rilasciato da OBELIS, Bd Général Wahis, 53 - B-1030 Brussels, BELGIUM

→ Mandatario CE (EC Representative) OBELIS, Bd Général Wahis, 53 - B-1030 Brussels, BELGIUM

CARATTERISTICHE

→ Mascherina a tre strati con strato interno filtrante in tessuto

“non tessuto” meltblown

→ Efficienza di filtrazione 98%

→ Colori: disponibili in 9 colori/

disegni

→ Dimensioni 130mm x 90mm

→ Nome: MaskLab Kids

→ Fabbricante: 3i Corporation Ltd.

MASCHERINA CHIRURGICA

DM classe I - tipo II per bambini 4-9 anni

www.italsalus.com

PACKAGING

→ Confezione da 50 mascherine confezionate singolarmente

→ Cartone contenente 40 scatole da 50 pz.

→ Dimensioni cartone cm 52x41x41

→ Peso cartone Kg. 9,37

Codice articolo M-01-K

MASCHERINA CHIRURGICA

DM classe I - tipo II

per bambini 4-9 anni Codice articolo M-01-K

MASCHERINA CHIRURGICA

DM classe I - tipo II

per bambini 4-9 anni Codice articolo M-01-K

MASCHERINA CHIRURGICA

DM classe I - tipo II

per bambini 4-9 anni Codice articolo M-01-K

MASCHERINA CHIRURGICA

DM classe I - tipo II

per bambini 4-9 anni Codice articolo M-01-K

CERTIFICATE

MDD NOTIFICATION

OF

EURO

PEANRESPONSIBLE PERSON CENTE R

KďĞůŝƐ ƵƌŽƉĞĂŶ ƵƚŚŽƌŝnjĞĚ ZĞƉƌĞƐĞŶƚĂƚŝǀĞ ĞŶƚĞƌ ŝƐ Ă ŵĞŵďĞƌ ŽĨ ƚŚĞ ƵƌŽƉĞĂŶ ƐƐŽĐŝĂƚŝŽŶ ŽĨ

ƵƚŚŽƌŝnjĞĚ ZĞƉƌĞƐĞŶƚĂƚŝǀĞƐ ;͘͘͘Z͘Ϳ͕ /^K ϵϬϬϭ ͗ ϮϬϭϱ ĂŶĚ /^K ϭϯϰϴϱ ͗ ϮϬϭϲ ĐĞƌƚŝĨŝĞĚ ŝŶ

ĂĐĐŽƌĚĂŶĐĞƚŽƚŚĞƉƌŽĨĞƐƐŝŽŶŽĨĂƵƌŽƉĞĂŶƵƚŚŽƌŝnjĞĚZĞƉƌĞƐĞŶƚĂƚŝǀĞ͘

Mr. G. Elkayam CEO

Obelis sa

Registered Address : Bd. Général Wahis 53 - 1030 Brussels I Registered Office Address : Bd Brand Whitlock 30, B-1200 Brussels - Belgium

T: + 32 (0) 2 732 5954 I F: + 32 (0) 2 732 6003 I Email: mail@obelis.net I Website: www.obelis.net V3 - ID: 00454516 - 22/02/2019

Ref. No.:GZ 9192-2020 Date: 14/05/2020

Order No.:GZ 9070-2020

This is to certify that, according to the Council Directive 93/42/EEC WE, HERE AT Obelis s.a. (O.E.A.R.C.) performed all notification duties and responsibilities as the European Authorized Representative (EC REP) of:

name: 3I Corporation Limited

address: Unit B, 4/F. Chiap King Ind Bldg, 114 King Fuk Street, San Po Kong, Kowloon, Hong Kong

as stipulated and demanded by the aforementioned directive.

The Manufacturer declares that the Class I * device complies with the Directive including all essential requirements.

The Manufacturer has provided Obelis s.a. (O.E.A.R.C.) with all the appropriate declarations as per the Council Directive 93/42/EEC article 11 requirements, including the EC Declaration of Conformity (according to Annex VII) confirming that their Class I medical device(s), as stipulated here below, is/are fulfilling the applicable requirements of the Council Directive 93/42/EEC.

The notification of the following medical device(s) has been completed by Obelis s.a. (O.E.A.R.C.) on the 13/05/2020 in compliance with the Council Directive 93/42/EEC - article 14 requirements.

Class I medical device: please see Annex A - List of Devices (1 Page, 1 device) As of the 14/05/2020 and as long as the Manufacturer will continue complying with the hereabove mentioned requirements**, he therefore:

- Is required to affix the CE marking on this device

- May place this device in the European Union and EEA territory,

* This is not a CE mark and is only provided as a template for informational purposes.

*Also applicable to Class Is and Im

** This Certificate will be automatically void if the notification is rejected by the EU Authorities or upon termination of the EAR agreement.

MASCHERINA CHIRURGICA

DM classe I - tipo II

per bambini 4-9 anni Codice articolo M-01-K

MASCHERINA CHIRURGICA

DM classe I - tipo II

per bambini 4-9 anni Codice articolo M-01-K

Test Report

This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com/en/Terms-and-Conditions.aspx and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com/en/Terms-and-Conditions/Terms-e-Document.aspx. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced except in full, without prior written approval of the Company. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law.

Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 30 days only.

3I CORPORATION LIMITED

RM 705, 7/F, K.WAH CENTRE,,191 JAVA ROAD,,NORTH POINT,,Hong Kong Job No. : HKHC200400001154

The following sample was submitted and identified by the client as surgical mask Product Description : surgical mask

Quantity Received : 3 bags Sample Appearance : Blue mask

SGS Sample No. : HKHC200400001154-101

Sample Receiving Condition : In unopened plastic bag under ambient condition Manufacturer : 3i Corporation Ltd

Country of Origin : Hong Kong Sample Receiving Date : Apr 02, 2020

Testing Period : Apr 02, 2020 – Apr 21 , 2020 Test Requested

1. To perform Bacterial Filtration Efficiency Test and Differential Pressure Test on the submitted sample.

2. To perform Particle Filtration Efficiency Test on the submitted sample.

3. To perform Synthetic blood fluid penetration resistance test on the submitted sample.

4. To perform Flammability test on the submitted sample.

Test Methods and Test Results Please refer to the following page(s).

**********

Signed for and on behalf of SGS Hong Kong Ltd.

_________________________________________

HO CHI MING, RICKY

SENIOR MANAGER - COSMETICS, PERSONAL CARE & HOUSEHOLD SERVICES

Signed for and on behalf of SGS Hong Kong Ltd.

_________________________________________

WONG KIN MAN, GILMAN

TECHNICAL DEVELOPMENT MANAGER - COSMETICS, PERSONAL CARE &

HOUSEHOLD SERVICES