13.1 Declaration of conformity
EC Declaration of Conformity
We,
Philipp Kirsch GmbH
Im Lossenfeld 14
77731 Willstätt-Sand
Germany
hereby declare on our sole authority that the devices of type BL described below, to which the declaration refers,
comply with the applicable requirements 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 58371:2010-09
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
Manufacturer
Device
category
Type
Serial numbers
from serial number
onwards
Basis-UDI-DI
KIRSCH
Refrigerator
BL 100 PRO-ACTIVE
100 32 25000
426068858BLPROACTIVEF4
KIRSCH
Refrigerator
BL 100 PRO-ACTIVE
100 03 25000
426068858BLPROACTIVEF4
KIRSCH
Refrigerator
BL 176 PRO-ACTIVE
170 30 25000
426068858BLPROACTIVEF4
KIRSCH
Refrigerator
BL 176 PRO-ACTIVE
170 04 25000
426068858BLPROACTIVEF4
KIRSCH
Refrigerator
BL 300 PRO-ACTIVE
280 31 25000
426068858BLPROACTIVEF4
KIRSCH
Refrigerator
BL 300 PRO-ACTIVE
280 09 25000
426068858BLPROACTIVEF4
KIRSCH
Refrigerator
BL 520 PRO-ACTIVE
500 32 25000
426068858BLPROACTIVEF4
KIRSCH
Refrigerator
BL 520 PRO-ACTIVE
500 06 25000
426068858BLPROACTIVEF4
KIRSCH
Refrigerator
BL 720 PRO-ACTIVE
700 31 25000
426068858BLPROACTIVEF4
KIRSCH
Refrigerator
BL 720 PRO-ACTIVE
700 03 25000
426068858BLPROACTIVEF4
KIRSCH
Refrigerator
BL 300 ULTIMATE
280 73 25000
426068858BLULTIMATENN
KIRSCH
Refrigerator
BL 300 ULTIMATE
280 83 25000
426068858BLULTIMATENN
KIRSCH
Refrigerator
BL 520 ULTIMATE
500 72 25000
426068858BLULTIMATENN
KIRSCH
Refrigerator
BL 520 ULTIMATE
500 82 25000
426068858BLULTIMATENN
KIRSCH
Refrigerator
BL 720 ULTIMATE
700 72 25000
426068858BLULTIMATENN
KIRSCH
Refrigerator
BL 720 ULTIMATE
700 82 25000
426068858BLULTIMATENN
0483
Appendix
Declaration of conformity
26.05.2021
Refrigerator/freezer BL series
76