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Per Mail: f.grob@dr-grob.com
Nachrichtlich: mpg-64.5@rpks.hessen.de
Im Antragsverfahren
5640-S-057/21Sonderzulassung
Dr. Grob Healthcare GmbH
Dr. Johannes Grob
Schumannstraße 27
60325 Frankfurt
Namens und in Vollmacht für den Hersteller
Beijing Hotgen Biotech Co.,Ltd
Janne Zhang
9 building, No.9 Tianfu Street
102600 Peking
„Antragsteller“
des Herstellers
Beijing Hotgen Biotech Co.,Ltd
Janne Zhang
9 building, No.9 Tianfu Street
102600 Peking
„Hersteller“
aufgrund des Antrags vom 19.02.2021
zum Medizinprodukt
Coronavirus (2019-nCoV)-Antigentest - „betroffenes Medizinprodukt“
auf Erteilung einer Sonderzulassung gemäß § 11 Absatz 1 Medizinproduktegesetz (MPG)
ergeht folgender
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 02.03.2021
GESCHZ 92.02- 5640 -S-057/21
BfArM, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn
Dr. Grob Healthcare GmbH
Dr. Johannes Grob
Schumannstraße 27
60325 Frankfurt
Deutschland
9


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