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    Balchem Corporation

    Balchem Corporation
    95 Balchem Lane
    Green Pond
    29446
    USA
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    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