Certificates provided by our notified body G-MED proving that our products comply:
• with the requirements of the Directive 98/79/EC Annex 1
or
• with the requirements of the IVDR Regulation (EU) 2017/746 Annex IV.
21 certificates are currently available.
Updated on May 22th, 2024
ECC n°08248 ABD Lys Download
ECC n°08383 Manual Range Download
ECC n°08394 EM Technology Download
ECC n°08428 Hemalys Download
ECC n°08615 HEMACELLS Download
ECC n°09280 Maestria Download
ECC n°09522 Phenokit Download
ECC n°09577 AnnexIV Download
ECC n°10492 AnnexVII Download
ECC n°10499 SeraCQI Download
ECC n°21598 Anti-D Weak Download
ECC n°24618 Safety Card Download
ECC n°32800 ABTest MULTI Download
ECC n°32801 ABTest Card Download
ECC n°33642 ABPAD & ABDPAD Download
ECC n°36142 ABD-Lys v2 Download
ECC n°38634 HEMATEST Download
ECC n°38968 NEG CONTROL Download
ECC n°39430 Annex IX chapters I and III Download
ECC n°39431 ABO-D & RH-KELL PK Download
ECC n°39732 Hema CQI Download