HABYS Sp. z o.o.

Authorized representative

🇵🇱 Poland

JARWIS sp. z o.o.

Authorized representative

🇵🇱 Poland·1 Manufacturer·13 Devices

Staleks Sp. z o.o.

Authorized representative

🇵🇱 Poland

PARAMEDYK Sp. z o.o.

Authorized representative

🇵🇱 Poland

NA

FDA UDI

GE Healthcare Finland Oy·00840682104081·

1434-MDR-010/2024

Certificate

MDR QMS·MIM Fertility Sp. z o.o.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

TNP/MDR/0021/4830/2024

Certificate

MDR QMS·INVENTMED Sp. z o. o.·TUV NORD Polska Sp. z o.o

TNP/MDR/003/0139/2022

Certificate

MDR QMS·FAMED ŻYWIEC SP. Z O.O.·TUV NORD Polska Sp. z o.o

HD 1967019-1

Certificate

MDD Annex II (excluding section 4)·APD-Medical Sp. z o.o.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

DD 60147392 0001

Certificate

MDD Annex V·OPTOPOL Technology Sp. z o.o.·TÜV Rheinland LGA Products GmbH·4 Basic UDI-DIs

1434-MDD-578/2019

Certificate

MDD Annex II (excluding section 4)·AIR PRODUCTS SP z o.o.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

DD 601485730001

Certificate

MDD Annex V·Messer Polska Sp. z o.o.·TÜV Rheinland LGA Products GmbH·10 Basic UDI-DIs

TNP/MDD/0365/4114/2021

Certificate

MDD Annex II (excluding section 4)·Bowil Biotech sp. z o.o.·TUV NORD Polska Sp. z o.o·6 Basic UDI-DIs

TNP/MDD/0365/4114/2021

Certificate

MDD Annex II (excluding section 4)·Bowil Biotech sp. z o.o.·TUV NORD Polska Sp. z o.o·17 Basic UDI-DIs

1434-MDD-587/2019

Certificate

MDD Annex II Section 4·Celther Polska Sp. z o.o.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·4 Basic UDI-DIs

DD601473920001

Certificate

MDD Annex V·OPTOPOL Technology Sp. z o.o.·TÜV Rheinland LGA Products GmbH·4 Basic UDI-DIs

CeCert/068/W/E.2

Certificate

IVDD Annex III Section 6·Hangzhou Laihe Biotech Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

CeCert/077/W/E.1

Certificate

IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

CeCert/115/W/E.1

Certificate

IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI

CeCert/116/W/E.1

Certificate

IVDD Annex IV (excluding sections 4, 6)·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI