Global Certifications & Compliance
Our products are designed to meet the highest standards of safety and efficacy. We are committed to maintaining compliance with international regulations and certifications, ensuring that our products are safe and effective for use in healthcare settings worldwide.
FDA Registration
Issuer:
U.S. Food & Drug Administration
Region:
United States
Registration Num:
3015140210
Certified Entity:
Jiangsu Ostup Medical Products Co. Ltd.
ISO 13485:2016 Certification
Issuer:
TÜV Rheinland LGA Products GmbH
Region:
Germany
Registration Num:
SX 2086020-1
Certified Entity:
Jiangsu Ostup Medical Products Co. Ltd.
EC Certificate (Annex V – Production Quality Assurance)
Issuer:
TÜV Rheinland LGA Products GmbH
Region:
European Union
Registration Num:
DD 60139846 0001
Certified Entity:
Jiangsu Ostup Medical Products Co. Ltd.
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