Certifications

At I’M MEDICARE, we believe that quality healthcare goes hand-in-hand with uncompromising safety and international standards. We are dedicated to maintaining the highest certifications—including CE, ISO, WHO, and EDGE—to guarantee the utmost reliability and trust in our products.

 

Our Certifications

EU Quality Management System Certificate

Regulation (EU) 2017/745 for Medical Devices, Annex IX Chapters I & III

NOTIFIED BY

Intertek Medical Notified Body AB

 

AUTHORIZED REPRESENTATIVE

EUCEREP B.V.

CLASSIFICATION

IIa

CLASSIFICATION

I (s,m)

CERTIFICATE NUMBER: 28620234405​

DATE OF ISSUE: 27 JANUARY 2026

CERTIFICATE NUMBER: 28620233274

DATE OF ISSUE: 20 JANUARY 2026

EU Quality Management System Certificate

Regulation (EU) 2017/745 for Medical Devices, Annex IX Chapters I & III

NOTIFIED BY

Intertek Medical Notified Body AB

 

AUTHORIZED REPRESENTATIVE

EUCEREP B.V.

CLASSIFICATION

IIa

CERTIFICATE NUMBER: 28620234405​

DATE OF ISSUE: 27 JANUARY 2026

CLASSIFICATION

I (s,m)

CERTIFICATE NUMBER: 28620233274

DATE OF ISSUE: 20 JANUARY 2026

(EN) ISO 13485:2016

(EN) ISO 13485:2016

CERTIFICATION AUTHORITY

Intertek Medical Notified Body AB

DATE OF ISSUE: 14 JANUARY 2026

WHO IMMUNIZATION DEVICES

E008: INJECTION DEVICES FOR IMMUNIZATION

PRODUCT NAME

0.5ML AD SYRINGE FOR FIXED DOSE IMMUNIZATION

 

IMD-PQS CODE

E008-125

DATE OF ISSUE: 20 AUGUST 2025

EDGE ADVANCED

EDGE ADVANCED

CERTIFIED BY

Green Business Certification Inc. (GBCI)

Energy Savings
65%
Water Savings
43%
Less Embodied Carbon in Materials
25%

DATE OF ISSUE: 29 MARCH 2024