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EC Certificate Production Quality Assurance Directive 93/42/EEC on Medical Devices (MOD), Annex V I ' (Devices in Class Ila, IIb or III) No. G211 0855416008 Manufacturer: Hrvatski Zavod Za Transfuzijsku Medicinu Petrova 3 10000 Zagreb CROATIA EC-Representative: KEMOFARMACIJA d.d., Ljubljana Cesta na Brdo 100 1000 Ljubljana REPUBLIC OF SLOVENIA Product Category(ies): Single use sterile medical devices for infusion and transfusion, catheters Product Service The Certification Body of TOV sOO Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for manufacture and final inspection of the respective devices I device categories in accordance with MOD Annex V. This quality assurance system conforms to the requirements of this Directive and is subject to periodical surveillance. For marketing of class IIb and III devices an additional Annex III certificate is mandatory. See also notes overleaf. Report No.: 71390979 Valid from: Valid until: 2011-12-05 2016-12-04 Date, 2011-11-18 Hans-Heiner Junker TOV sOO Product Service GmbH is Notified Body with identification no. 0123 Page 1 of 2 TOV sOO Product Service GmbH . Zertifizierstelle . Hidlerstralše 65 . 80339 Munchen . Germany

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EC CertificateProduction Quality AssuranceDirective 93/42/EEC on Medical Devices (MOD), Annex V I '

(Devices in Class Ila, IIb or III)

No. G211 0855416008

Manufacturer: Hrvatski Zavod Za TransfuzijskuMedicinuPetrova 310000 ZagrebCROATIA

EC-Representative: KEMOFARMACIJA d.d., LjubljanaCesta na Brdo 1001000 LjubljanaREPUBLIC OF SLOVENIA

ProductCategory(ies):

Single use sterile medical devices for infusionand transfusion, catheters

Product Service

The Certification Body of TOV sOO Product Service GmbH declares that the aforementionedmanufacturer has implemented a quality assurance system for manufacture and final inspectionof the respective devices I device categories in accordance with MOD Annex V. This qualityassurance system conforms to the requirements of this Directive and is subject to periodicalsurveillance. For marketing of class IIb and III devices an additional Annex III certificate ismandatory. See also notes overleaf.

Report No.: 71390979

Valid from:Valid until:

2011-12-052016-12-04

Date, 2011-11-18Hans-Heiner Junker

TOV sOO Product Service GmbH is Notified Body with identification no. 0123

Page 1 of 2

TOV sOO Product Service GmbH . Zertifizierstelle . Hidlerstralše 65 . 80339 Munchen . Germany

Page 2: EC Certificate - hztm.hr i G2S.pdfEC Certificate Production Quality Assurance Directive 93/42/EEC on Medical Devices (MOD), Annex V I ' (Devices in Class Ila, IIb or III) No. G211

Product Service

EC CertificateProduction Quality AssuranceDirective 93/42/EEC on Medical Devices (MOD), Annex V(Devices in Class Ila, IIb or III)

No. G211 0855416008

I '

Facility(ies): Hrvatski Zavod Za Transfuzijsku MedicinuPetrova 3,10000 Zagreb, CROATIA

Page 2 of 2

TOV sOO Product Service GmbH . Zertifizierstelle . Hidlerstrafše 65 . 80339 MOnchen . Germany 11JV®

EC CertificateProduction Quality AssuranceDirective 93/42/EEC on Medical Devices (MOD), Annex V I '

(Devices in class I in sterile conditions, sterilised systems or procedure packs)

No. G2S 11 0855416007

Manufacturer: Hrvatski Zavod Za TransfuzijskuMedicinuPetrova 310000 Zagreb

CROATIA

EC-Representative: KEMOFARMACIJA d.d., LjubljanaCesta na Brdo 1001000 LjubljanaREPUBLIC OF SLOVENIA

ProductCategory(ies):

Single use sterile medical devices for infusionand transfusion, catheters, oxygen therapy(class I sterile)

Product Service

The Certification Body of TOV sOO Product Service GmbH declares that the aforementionedmanufacturer has implemented a quality assurance system for manufacture in accordance withMOD Annex V. This quality assurance system covers those aspects of manufacture concernedwith securing and maintaining sterile conditions of the respective devices I device categories andconforms to the requirements of this Directive. It is subject to periodical surveillance. See alsonotes overleaf.

Report No.: 71390979

Valid from:Valid until:

2011-12-05

2016-12-04

Date, 2011-11-18Hans-Heiner Junker

TOV SOO Product Service GmbH is Notified Body with identification no. 0123

Page 1 of 2

ruv SOD Product Service GmbH . Zertifizierstelle . Hidlerstralše 65 . 80339 Munchen . Germany

Page 4: EC Certificate - hztm.hr i G2S.pdfEC Certificate Production Quality Assurance Directive 93/42/EEC on Medical Devices (MOD), Annex V I ' (Devices in Class Ila, IIb or III) No. G211

EC CertificateProduction Quality AssuranceDirective 93/42/EEC on Medical Devices (MOD), Annex V .(Devices in class I in sterile conditions, sterilised systems or'procedure packs)

No. G2S 11 0855416007

Facility(ies): Hrvatski Zavod Za Transfuzijsku MedicinuPetrova 3, 10000 Zagreb, CROATIA

Page 2 of 2

TOV SOD Product Service GmbH . Zertifizierstelle . Hidlerstralše 65 . 80339 MOnchen . Germany

Product Service

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