Certificate

CE-ID Manufacturing – Standard of Excellence

For IFU, MSDS, CoA, Batch Certificate and others, please do not hesitate to contact our team of experts, using the contact information below. customized blood typing


Certified DIN EN ISO 13485:2012


Reagents are manufactured at our own facility and are certified and licensed with complete donor traceability and safety documents. All are 100% inspected for visual clarity and color. All products manufactured and distributed are CE conform according to the European Directive 98/79/EC on in-vitro diagnostics medical devices. All manufacturing processes fully comply with the requirements of GMP.


CE-ID has a long record of experience. Already in 1996, we built up first quality management according to DIN EN ISO 9001. In order to stay up to date, we implemented the Quality Management System according to DIN EN ISO 13485 in its work processes  already in 2003.


D1415300024_CE Anhang IV.4_ABO_E_1
D1415300024_CE Anhang IV.4_ABO_E_2
D1415300023_CE Anhang IV.4_Kell_E_1
D1415300023_CE Anhang IV.4_Kell_E_2
D1415300022_CE Anhang IV.4_Rh_E_1
D1415300022_CE Anhang IV.4_Rh_E_2
D1415300025_E
D1415300028_E_sig
Q system EN
Statement Annex IV.4_fehlende Seiten_20220530
Declaration of Conformity
Declaration of Conformity._2025.02.pdf (2.78MB)
Declaration of Conformity
Declaration of Conformity._2025.02.pdf (2.78MB)


Konformität
Konformitätserklärung
Konformitätserklärung.pdf (2.79MB)
Konformität
Konformitätserklärung
Konformitätserklärung.pdf (2.79MB)


 
 
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