Manufacturer's By Device Oral/upper respiratory tract specimen collection swab-Oral/upper respiratory tract specimen collection swab Conformity Assessment Certificate Expired, Oral/upper respiratory tract specimen collection swab

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Andersen Caledonia LtdCaledonian House Phoenix Crescent Strathclyde Business Park

Bellshill
Lanarkshire ML4 3NJ

Scotland United Kingdom





06/23/20103335
BioTeke Corporation (Wuxi) Co. Ltd4th Floor D5 & 2nd Floor D3 & 1st and 2nd Floor D16 No. 1719 Huishan Avenue Wuxi

Jiangsu Province
214174

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
04/21/202112460
BioTeke Corporation (Wuxi) Co. Ltd4th Floor D5 & 2nd Floor D3 & 1st and 2nd Floor D16 No. 1719 Huishan Avenue Wuxi

Jiangsu Province
214174

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
04/21/202112460
DNA Genotek Inc.3000 - 500 Palladium Drive

Ottawa
Ontario K2V 1C2

Canada
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
12/06/202120345
DNA Genotek Inc.3000 - 500 Palladium Drive

Ottawa
Ontario K2V 1C2

Canada
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
12/06/202120345
DNA Genotek Inc.3000 - 500 Palladium Drive

Ottawa
Ontario K2V 1C2

Canada
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
12/06/202120345
Guangzhou Improve Medical Instruments Co. Ltd.No.102 Kaiyuan Avenue Science City Guangzhou Economic & Technological Development District

Guangzhou
510530

China
Etheria Medical LtdThe Old brush Factory Unit 2D Whickham Industrial Estate Swalwell

Newcastle Upon Tyne
NE16 3DA

United Kingdom
04/15/202221468
HAIMEN SHENGBANG LABORATORY EQUIPMENT CO. LTDNo.126 Group 9 Zhangbei Village Haimen

Jiangsu Province
226110

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
06/28/202225070
Hunt Developments (UK) LtdUnit 15-18 Holmbush Industrial Estate

Midhurst
West Sussex GU29 9HX

United Kingdom





04/05/20222607
Jiangsu Mole Bioscience Co. Ltd.6-7th Floor G116 Building No. 805 Jiankang Avenue Medical New & Hi-tech District Taizhou

Jiangsu Province
225300

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
03/05/202112478
Jiangsu Rongye Technology Co. Ltd.Touqiao Town Yangzhou City

Jiangsu Province
225109

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
11/14/202226934
Merit Medical Systems Inc.1600 West Merit Parkway
1600 West Merit Parkway
South Jordan
Utah 84095

United States
Merit Medical UK LimitedUnit 27 Suttons Business Park Sutton Park Avenue Earley Reading Berkshire RG6 1AZ United Kingdom

Reading
Berkshire RG6 1AZ

England United Kingdom
03/05/202112487
Miraclean Technology Co. Ltd.Room 301 Building A No.18 Rongshuxia Industrial Zone Tongxin Community
Baolong Street Longgang District
Shenzhen
Guangdong 518116

China
SHARE INFO LTD3rd Floor Office C Townend House Park Street

Walsall
West Midlands WS1 1NS

England United Kingdom
06/17/202115324
RhinoMed LimitedLevel 1 132 Gwynne Street

Richmond Victoria
3121

Australia
MDSS-UK RP LIMITED6 Wilmslow Road Rusholme

Manchester
M14 5TP

England United Kingdom
04/26/202224356
Shenzhen Huaree Technology Co. Ltd101 201 No. 17 Shouli Road Central Community Pingdi Street Longgang District Shenzhen

Guangdong Province
518117

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
07/25/202225401
Shenzhen KangDaAn Biological Technology Co. Ltd.East-1 3rd floor Building 2 Shunheda factory Liuxiandong industrial zone Xili street
Nanshan district
Shenzhen
Guangdong 518055

China
SHARE INFO LTD3rd Floor Office C Townend House Park Street

Walsall
West Midlands WS1 1NS

England United Kingdom
06/08/202115238
Shenzhen MandeLab Co. Ltd.7F & 6F Building #5 10th Industrial Zone Tianliao Community Yutang Street Guangming District Shenzhen

Guangdong Province
518132

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
04/05/202224016
Shenzhen Zijian Biotechnology Co. Ltd.502 Building A Qiaode Science Park No.7 Guangming Hi-tech Park West Tianliao Community Yutang Street Guangming District

Shenzhen
Guangdong Province 518017

China
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
09/09/202225859
SteriPack USA Limited4255 South Pipkin Road

Lakeland
Florida 33811

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
01/24/202222063
Young Innovations Inc2260 Wendt St

Algonquin
IL 60102

United States
Astek Innovations LtdAstek House Atlantic St

Altrincham
WA14 5DH

United Kingdom
04/30/202114268