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Per Mail: andreas.fu@clongene.com
Nachrichtlich: shholding@hotmail.com; medizinpro-
dukte@justiz.hamburg.de
Im Verfahren der Erteilung einer Sonderzulassung gemäß § 11 Abs. 1 MPG
5640-S-168/21 Sonderzulassung
aufgrund des Antrags vom 08.03.2021
für das Medizinprodukt
COVID-19 Antigen Rapid Test „betroffenes Medizinprodukt“
An
Hangzhou Clongene Biotech Co., Ltd.
Mr. Andreas FU
No.1 Yichuang Road, Yuhang Sub-district,
Yuhang District
311121 Hangzhou
„Inhaber der Sonderzulassung“
des Unternehmens
s.o. „Inhaber der Sonderzulassung“ „Hersteller“
mit dem europäischen Bevollmächtigten gem.
§ 3 Ziff. 16 MPG
Shanghai International Holding Corp. GmbH
(Europa)
Eiffestraße 80
D-20537 Hamburg
„Europäischer Bevollmächtigter“ und
Verantwortlicher nach § 5 MPG
ABTEILUNG Medizinprodukte
BEARBEITET VON Kerstin Brandenburg
TEL +49 (0)228 99 307- 3373
E-MAIL Kerstin.Brandenburg@bfarm.de
HAUSANSCHRIFT Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
TEL +49 (0)228 99 307-0
FAX +49 (0)228 99 307-5207
E-MAIL poststelle@bfarm.de
INTERNET www.bfarm.de
Bonn, den 16.03.2021
GESCHZ 92.02-5640 -S-168/21
BfArM, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn
Shanghai International Holding Corp. GmbH (Europa)
Liang Jin
Eiffestraße 80
D-20537 Hamburg
10


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