Gke-Mbh
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Web: http://gke-mbh.de
E-Mail:
Address: Esch, Auf Der Lind 10, Waldems 65529, Germany
Phone: +49-(612)-69432-0 | Fax: +49-(612)-6943210 | Map/Directions >>
Web: http://gke-mbh.de
E-Mail:
Address: Esch, Auf Der Lind 10, Waldems 65529, Germany
Phone: +49-(612)-69432-0 | Fax: +49-(612)-6943210 | Map/Directions >>
Profile: Gke-Mbh specializes in sterilization design, validation and monitoring. We develop and validate steam, formaldehyde, ethylenoxide and hydrogen peroxide/plasma sterilization processes. We produce biological and chemical indicators with process-challenge-devices for sterilization monitoring. We offer self adhesive documentation labels and seals with process indicators. We also provide OEM production for sterilization monitoring and accessories for sterilization.
The company has revenues of USD 5-10 Million, has ~20 employees and is ISO 9001, CE certified.
FDA Registration Number: 3008925937
US Agent: Jean Bigoney / Nu Device Consulting Llc
Phone: +1-(603)-865-3565 Fax: +1-(603)-869-7669 E-Mail:
4 Products/Services (Click for related suppliers)
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| • Biological Sterilization Process Indicator (FDA Code: FRC / 880.2800) A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. |
| • Chemical Sterilization Process Indicator |
| • Hydrogen Peroxide Sterilization Monitors |
| • Sterilization Indicators (FDA Code: LRT / 880.2800) |
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