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DECLAR Doc MANUFACTURER: Medical Device : CLASSIFICATION-ANNEX IX: CONFORMITY ASSESSMENT R APPLIED STANDARD(S): WE, JIANGSU WEIKANG JIEJIN THE STATED MEDICAL DEVICE OF COUNCIL DIRECTIVE 93/42 ALL SUPPORTING DOCUMENTION THE MANUFACTURER IS EXCLUS IDENTIFICATION NUMBER (EC) Certificate(S): EXP. DATE: EUROPEAN REPRESENTATI START OF CE-MARKING: PLACE ,DATE OF DECLARAT SIGNATURE: RATION OF CONFORMIT cument No. DOC-2020031001 Jiangsu Weikang Jiejing Medical Apparatu 18#, Wenzhou Rd. Economical Developm Shuyang, 223600 Jiangsu, China Tel: 0527-80817125 80817128 Email:[email protected] Disposable Medical Face Mask WKM20-19, WKM20-20, WKM20 : Class I,Rule 1 ROUTE: MDD 93/42/EEC Annex VII EN14683:2019 NG MEDICAL APPARATUS CO., LTD. HERE MEET THE TRASPOSITION INTO NATIONAL 2/EEC CONCERNING MEDICAL DEVICES; N IS RETAINED AT THE PERMISES OF TH SIVELY RESPONSIBLE FOR THE DECLARATIO R: / / Lotus NL B.V. IVE : Koningin Julianaplein 10,1e Verd, 259 Netherlands. Tel:+36441068999 E-mail：[email protected] TION: <SHU YANG> ,2020-04-30 NAME:Camel Zhou POSITION: QUALITY MANAGEMENT/REPRE TY us Co., Ltd. ment District, 0-21, WKM20-22 E WITH DECLARE THAT LAW,THE PROVISIONS HE MANUFACTURER,AND ON OF CONFORMITY. 95AA, The Hague, ESENTATIVE

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Page 1: DECLARATION OF CONFORMITY - Amazon Web Services

DECLARATION OF CONFORMITYDocument No. DOC

MANUFACTURER:

Medical Device :

CLASSIFICATION-ANNEX IX: CONFORMITY ASSESSMENT ROUTE:APPLIED STANDARD(S): WE, JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO.,

THE STATED MEDICAL DEVICE MEET THE TRASPOSITION INTO NATIONAL LAW,THE PROVISIONS

OF COUNCIL DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES;

ALL SUPPORTING DOCUMENTION IS RETAINED AT THE PERMISES OF THE MANUFACTURER,AND

THE MANUFACTURER IS EXCLUSIVELY RESPONSIBLE FOR THE DECLARATION OF CONFORMITY.

IDENTIFICATION NUMBER:

(EC) Certificate(S):

EXP. DATE:

EUROPEAN REPRESENTATIVE

START OF CE-MARKING: PLACE ,DATE OF DECLARATION: <SHU YANG> ,2020

SIGNATURE:

DECLARATION OF CONFORMITYDocument No. DOC-2020031001

Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.18#, Wenzhou Rd. Economical Development District, Shuyang, 223600 Jiangsu, China

Tel: 0527-80817125 80817128 Email:[email protected]

Medical Device : Disposable Medical Face Mask WKM20-19, WKM20-20, WKM20

ANNEX IX: Class I,Rule 1 CONFORMITY ASSESSMENT ROUTE: MDD 93/42/EEC Annex VII APPLIED STANDARD(S): EN14683:2019

JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD. HERE WITH DECLARE THAT

THE STATED MEDICAL DEVICE MEET THE TRASPOSITION INTO NATIONAL LAW,THE PROVISIONS

OF COUNCIL DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES;

ALL SUPPORTING DOCUMENTION IS RETAINED AT THE PERMISES OF THE MANUFACTURER,AND

THE MANUFACTURER IS EXCLUSIVELY RESPONSIBLE FOR THE DECLARATION OF CONFORMITY.

IDENTIFICATION NUMBER:

(EC) Certificate(S): / /

Lotus NL B.V.

EUROPEAN REPRESENTATIVE : Koningin Julianaplein 10,1e Verd, 2595AA, The Hague, Netherlands. Tel:+36441068999 E-mail：[email protected]

ARATION: <SHU YANG> ,2020-04-30

SIGNATURE:

NAME:Camel Zhou

POSITION:

QUALITY MANAGEMENT/REPRESENTATIVE

DECLARATION OF CONFORMITY

Jiejing Medical Apparatus Co., Ltd. 18#, Wenzhou Rd. Economical Development District,

, WKM20-21, WKM20-22

HERE WITH DECLARE THAT

THE STATED MEDICAL DEVICE MEET THE TRASPOSITION INTO NATIONAL LAW,THE PROVISIONS

ALL SUPPORTING DOCUMENTION IS RETAINED AT THE PERMISES OF THE MANUFACTURER,AND

THE MANUFACTURER IS EXCLUSIVELY RESPONSIBLE FOR THE DECLARATION OF CONFORMITY.

Koningin Julianaplein 10,1e Verd, 2595AA, The Hague,

QUALITY MANAGEMENT/REPRESENTATIVE

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