We also declare that the devices of type FROSTER-BL described below, to which the declaration refers, comply
with the conformity assessment procedure according of Directive 93/42 EEC for medical devices.
The devices belong to Class IIa according to Appendix IX of the Directive above. The named authority, mdc medical
device certification GmbH, Kriegerstraße 6, 70191 Stuttgart, s included in the conformity procedure according to
Appendix II of Directive 93/42/EEC.
Registration-Nr.: D1423300012
We furthermore declare that the devices described below comply with the applicable requirements of the RoHS
Directive 2011/65/EC and the protection requirements of the standards below at the time that the device was placed
on the market.
Standards
DIN EN ISO 9001:2015
DIN EN ISO 13485:2016
DIN EN ISO 14971:2020
DIN 58375:2004-11
Harmonised standards
EN 61010-1:2010+A1:2019
EN 61010-2-11:2017
EN 60601-1-2:2015
EN/IEC 61000-3-2:2014
EN/IEC 61000-3-3:2013
Willstätt, 20.05.2021
Dr. Jochen Kopitzke
Managing Director
Manufacturer
Device
category
Type
Serial numbers
from serial number
onwards
Basis-UDI-DI
KIRSCH
Freezer
FROSTER BL 178 PRO-ACTIVE
170 05 25000
426068858BLFROSTERPAJD
KIRSCH
Freezer
FROSTER BL 180 PRO-ACTIVE
180 01 25000
426068858BLFROSTERPAJD
KIRSCH
Freezer
FROSTER BL 330 PRO-ACTIVE
320 02 25000
426068858BLFROSTERPAJD
KIRSCH
Freezer
FROSTER BL 530 PRO-ACTIVE
500 10 25000
426068858BLFROSTERPAJD
KIRSCH
Freezer
FROSTER BL 650 PRO-ACTIVE
650 01 25000
426068858BLFROSTERPAJD
KIRSCH
Freezer
FROSTER BL 730 PRO-ACTIVE
700 06 25000
426068858BLFROSTERPAJD
KIRSCH
Freezer
FROSTER BL 330 ULTIMATE
320 82 25000
426068858BLFROSTERULTP2
KIRSCH
Freezer
FROSTER BL 530 ULTIMATE
500 86 25000
426068858BLFROSTERULTP2
KIRSCH
Freezer
FROSTER BL 730 ULTIMATE
700 86 25000
426068858BLFROSTERULTP2
0483
Appendix
Declaration of conformity
26.05.2021
Refrigerator/freezer BL series
77