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RADIO TEST REPORT

Radio Equipment Item 8 of Article 2 Paragraph 1


Specified low-power equipment for implant medical data transmission

Report Reference No. .................... : G0M-1803-7311-TJP208ME-V02

Testing Laboratory ........................ : Eurofins Product Service GmbH

Address ............................................ : Storkower Str. 38c


15526 Reichenwalde
Germany

Accreditation .................................... : None

Applicant’s name ........................... : BIOTRONIK SE & Co. KG

Address ............................................ : Woermannkehre 1


12359 Berlin
GERMANY

Test specification:

Standard........................................... : 特定無線設備の技術基準適合証明等に関する規則
Ordinance concerning Technical Regulations Conformity
Certification etc. of Specified Radio Equipment
Article 2, Clause 1, Item 8
無線設備規則
Ordinance Regulating Radio Equipment
Article 49.14.3 and dedicated articles

Non-standard test method…………..: None

Test scope………….. ....................... : complete Radio compliance test

Equipment under test (EUT):

Product description ICD-4200 / Implantable Cardioverter Defibrillator

Model No. Acticor 7 HF-T

Additional Model(s) None

Brand Name(s) BIOTRONIK

Hardware version Rev.: 0A

Firmware / Software version RAM: 5.0 / ROM: 5.0

Test result Passed

Test Report No.: G0M-1803-7311-TJP208ME-V02


Eurofins Product Service GmbH
Storkower Str. 38c, D-15526 Reichenwalde, Germany
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