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- EN ISO13485:2016
EN ISO13485:2016
EN ISO13485:2016
Certificate Overview: This document is a certification issued by TÜV SÜD Product Service GmbH to CALTH Inc., located in the Republic of Korea. The certificate confirms that CALTH Inc. has established and maintains a quality management system compliant with the EN ISO 13485:2016 standard, which pertains to medical devices and quality management systems for regulatory purposes.
Scope of Certification: The certification covers the design, development, production, and distribution of in-vitro diagnostic reagents and instruments specifically for Point of Care Testing (POCT) using rapid immunochromatographic assays.
Validity: The certificate is valid from June 16, 2023, to June 15, 2026.
Facilities: The certification applies to multiple CALTH Inc. facilities in Gyeonggi-do, Republic of Korea, each responsible for different aspects of the production and distribution process:
- #321, 54 Changeop-ro, Sujeong-gu, Seongnam-si: Distribution of in-vitro diagnostic reagents.
- #7508, 140, Beolmal-ro, Dongan-gu, Anyang-si: Design and development of in-vitro diagnostic reagents.
- #1201~1203, #1215~1218, #1306, 52, Gongdan-ro 140beon-gil, Gunpo-si: Production and distribution of in-vitro diagnostic reagents and instruments.
Certification Details: The certificate number is Q5 107415 0001 Rev. 02, and the report number is 74964908. The certification body is located in Munich, Germany, and the certificate was signed by Christoph Dicks, Head of Certification/Notified Body.
Catalog excerpts
CertificateNo. Q5 107415 0001 Rev. 02 Holder of Certificate: CALTH Inc. #321,54 Changeop-ro, Sujeong-gu Seongnam-si, Gyeonggi-do 13449 REPUBLIC OF KOREA Scope of Certificate: Design, Development, Production andDistribution of In-Vitro Diagnostic Reagents for POCT(Rapid immunochromatographic assay)Production and Distribution of In-Vitro Diagnostic Instruments for POCT(Rapid immunochromatographic assay) The Certification Body of TUV SUD Product Service GmbH certifies that the company mentioned above has established and is maintaining a quality management system, which meets the requirements of the listed standard(s). All applicable requirements of the testing and certification regulation of TUV SUD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?q=cert:Q5 107415 0001 Rev. 02 Valid from: Valid until: Date, 2023-05-31 Chnst°ph Dicks Head of Certification/Notified Body TUV SUD Product Service GmbH • Certification Body • Ridlerstrafce 65 • 80339 Munich • Germany
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CertificateNo. Q5 107415 0001 Rev. 02 Applied Standard(s): EN ISO 13485:2016 Medical devices - Quality management systems -Requirements for regulatory purposes (ISO 13485:2016) Facility(ies): calth Inc. #321,54 Changeop-ro, Sujeong-gu, Seongnam-si, Gyeonggi-do 13449, REPUBLIC OF KOREA Distribution of In-Vitro Diagnostic Reagents for POCT (Rapid immunochromatographic assay) CALTH Inc. #7508, 140, Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do 14057, REPUBLIC OF KOREA Design and Development of In-Vitro Diagnostic Reagents for POCT (Rapid immunochromatographic assay) CALTH Inc. #1201~1203, #1215~1218,...
Open the catalog to page 2- Detection kit
- Immunoassay detection kit
- Rapid chromatographic immunoassay test
- Immunoassay rapid diagnostic test
- Cassette rapid test
- Rapid virus test
- Chromatographic immunoassay test kit
- Rapid respiratory disease test
- Urine detection kit
- COVID-19 rapid test
- POC analyzer
- Hormone test kit
- Rapid nasal test
- Self-test rapid test
- Gynecology test kit
- Self-test test kit
- Pregnancy assay kit
- POC analyzer with touchscreen
- Infectious disease POC reader
- Benchtop POC reader