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Certification

XINKANG MEDICAL INSTRUMENT CO.,LTD. Certifications
Standard: EN ISO 13485
Number: Q5 104670 0001 Rev. 00
Issue Date: 2024-04-26
Expiry Date: 2027-04-25
Scope/Range: Design and Development, Production and Distribution of Reusable SpO2 sensors, Disposable SpO2 sensors
XINKANG MEDICAL INSTRUMENT CO.,LTD. Certifications
Standard: PEOPLE'S REPUBLIC OF CHINA CERTIFICATE FOR EXPORTATION OF MEDICAL PRODUCTS
Number: 粤食药监械出20251531号
Issue Date: 2025-09-16
Expiry Date: 2027-09-15
Scope/Range: Reusable SpO2 sensors
XINKANG MEDICAL INSTRUMENT CO.,LTD. Certifications
Standard: PEOPLE'S REPUBLIC OF CHINA CERTIFICATE FOR EXPORTATION OF MEDICAL PRODUCTS
Number: 粤食药监械出20251532号
Issue Date: 2025-09-16
Expiry Date: 2027-09-15
Scope/Range: Disposable SpO2 sensors
XINKANG MEDICAL INSTRUMENT CO.,LTD. Certifications
Standard: PEOPLE'S REPUBLIC OF CHINA CERTIFICATE FOR EXPORTATION OF MEDICAL PRODUCTS
Number: 粤食药监械出20251533号
Issue Date: 2025-09-16
Expiry Date: 2027-09-15
Scope/Range: Temperature Probe
XINKANG MEDICAL INSTRUMENT CO.,LTD. Certifications
Standard: PEOPLE'S REPUBLIC OF CHINA CERTIFICATE FOR EXPORTATION OF MEDICAL PRODUCTS
Number: 粤食药监械出20251578号
Issue Date: 2025-09-19
Expiry Date: 2025-09-18
Scope/Range: Reusable ECG Electrode
XINKANG MEDICAL INSTRUMENT CO.,LTD. Certifications
Standard: Certification of FDA Registration Service
Number: FDA 202511-240
XINKANG MEDICAL INSTRUMENT CO.,LTD. Certifications
Standard: PEOPLE'S REPUBLIC OF CHINA CERTIFICATE FOR EXPORTATION OF MEDICAL PRODUCTS
Number: 粤食药监械出20250003号
Scope/Range: NIBP Cuff
XINKANG MEDICAL INSTRUMENT CO.,LTD. Certifications
Standard: PEOPLE'S REPUBLIC OF CHINA CERTIFICATE FOR EXPORTATION OF MEDICAL PRODUCTS
Number: 粤食药监械出20250002号
Scope/Range: ECG Cable
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