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    Solventum Poland Manufacturing Sp z.o.o.

    Solventum Poland Manufacturing Sp z.o.o.
    ul. Kwidzynska 6
    Wroclaw
    51-416
    Poland
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    Certificate number: MDR 725200
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/745 Annex IX Chapter I and III 2022-10-06 2027-10-05

    Certificate number: MDR 725201
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    Art 22 (EU) 2017/745 Annex XI Part A 2022-02-07 2027-02-06

    Certificate number: MDR 725202
    Scope: View Scope(PDF)

    Standard/Scheme number or name Start Date Expiry Date
    (EU) 2017/745 Annex XI Part A 2021-02-08 2026-02-07

    Certificate number: UKCA 763340
    Scope: The design and manufacture of electrosurgical plates, sterile medicated drapes, sterile medicated transparent film dressings, ethylene oxide gas sterilizers and cartridges, temperature monitoring sensors and controller, pressure infusion regulators, blood/fluid warming units, fluid warming units and sterile disposable sets for irrigation, and patient warming units.

    Standard/Scheme number or name Start Date Expiry Date
    UK MDR Part II Annex II Sec 3.2 2023-01-04 2030-03-16

    Certificate number: UKCA 763342
    Scope: The manufacture and final inspection of sterile transparent wound dressings, barrier film dressings, and sterile disinfecting port protector devices. Those aspects of Annex V relating to securing and maintaining sterility of wound dressings, barrier film wraps, patient warming blankets and securement devices.

    Standard/Scheme number or name Start Date Expiry Date
    UK MDR Part II Annex V Sec 3.2   2022-12-20 2030-03-15

    Certificate number: CE 00493
    Scope: The manufacture of sterile transparent wound dressings with and without pads, electronic stethoscopes and associated software, sterile skin staplers and sterile drapes (wound protector, isolation bag), barrier film dressings, and sterile disinfecting port protector devices. Those aspects of Annex V relating to securing and maintaining sterility in the manufacture of wound closures, wound dressings, drapes, barrier film wraps, staple removers, patient warming blankets and securement devices. Those aspects of manufacturing relating to obtaining sterility in the assembly of procedure packs in accordance with Article 12 of the Medical Device Directive.

    Standard/Scheme number or name Start Date Expiry Date
    93/42/EEC Annex V, Section 3.2 (2007/47) 1995-02-01 2024-05-26

    Certificate number: CE 02242
    Scope: The design and manufacture of electrosurgical plates, sterile medicated drapes, sterile medicated transparent film dressings, ethylene oxide gas sterilizers and cartridges, temperature monitoring sensors and controller, pressure infusion regulators, blood/fluid warming units and sterile disposable sets for infusion, fluid warming units and sterile disposable sets for irrigation, and patient warming units. The design and manufacture of sterile wound dressings (non-medicated): - adhesive foam - non-adhesive foam - hydrocolloid - alginate - absorbent clear acrylic - non adherent - hydrogels

    Standard/Scheme number or name Start Date Expiry Date
    93/42/EEC Annex II, Sec 3.2 (2007/47) 1999-02-12 2024-05-26