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Per Mail: hotgen@hotgen.com.cn;
f.grob@dr-grob.com
Nachrichtlich: ecrep@medneteurope.com;
mitteilungen-dimdi@brms.nrw.de
Ihre Sonderzulassung mit Bescheid vom 02.03.2021, 5640 -S-057/21
zuletzt geändert mit Bescheid vom 31.05.2021
Im Verfahren der befristeten Verlängerung Ihrer Sonderzulassung gemäß § 11 Abs. 1 MPG
5640-S-057/21
aufgrund des Verlängerungsantrags vom
23.04.2021
an
Beijing Hotgen Biotech Co.,Ltd
9 building, No.9 Tianfu Street
102600 Peking
China
„Inhaber der Sonderzulassung”
im Antragsverfahren vertreten durch
Dr. Grob Healthcare GmbH
Schumannstraße 27
60325 Frankfurt
für das Medizinprodukt
Coronavirus (2019-nCoV)-Antigentest - „betroffenes Medizinprodukt“
des Unternehmens
s.o. „Inhaber der Sonderzulassung“ „Hersteller“
mit dem europäischen Bevollmächtigten gem.
§ 3 Ziff. 16 MPG
MedNet GmbH
Borkstraße 10
48163 Münster
„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 31.05.2021
GESCHZ 5640-S-057/21
BfArM, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn
Dr. Grob Healthcare GmbH
Schumannstraße 27
60325 Frankfurt
15


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