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.

We, DIAGAST, located at 251 avenue Eugène Avinée, 59120 Loos (France), represented by Mr. José BOIGNARD Regulatory Affairs Manager, certify that in accordance with Article 2 of Regulation (EU) 2017/746, as amended by Regulation (EU) 2024/1860, the EC certificates and attestations issued by our notified body (GMED), as well as our EC declarations of conformity, in accordance with Directive 98/79/EC, continue to remain valid during transitional provisions as described below:

December 31, 2027 for the following Class D devices:

DESIGNATIONREFDESIGNATIONREF
ANTI-A (ABO1) 5 x 10 ml70501SAFETY TEST ABO79069
ANTI-B (ABO2) 5 x 10 ml70502SAFETY CARD AB79074
ANTI-A,B (ABO3) 5 x 10 ml70503SAFETY CARD AB79075
ANTI-A (ABO1) 100 x 10 ml70540SAFETY CARD AB79076
ANTI-B (ABO2) 100 x 10 ml70541ABTest Card79070
ANTI-A,B (ABO3) 100 x 10 ml70542ABTest Card ES-PT79100
ANTI-D (RH1) IgM I 100 x 10 ml70543ABTest Card EN-DE79090
ANTI-D (RH1) TOTEM 100 x 10 ml70544ABTest MULTI79080
GROUPAKIT70888ABD PAD40102
ANTI-D (RH1) IgM I 5 x 10 ml71000DuoLys79960
ANTI-D (RH1) IgM II 5 x 10 ml71005PhenoLys79962
ANTI-D (RH1) TOTEM 5 x 10 ml71010Groupa 2 Lys79964
ANTI-D (RH1) IgG 5 x 10 ml71020Groupa A1 Lys79965
ANTI-DCE (RH1,2,3) 5 x 5 ml74111Pheno 1,2 Lys79966
NEG CONTROL 5 x 10 ml79000Groupa DVI Lys79969
ANTI-c (RH4)74011DuoLys v279970
ANTI-C (RH2)74221PhenoLys v279971
ANTI-E (RH3)74311Pheno 1,2 Lys v279972
ANTI-e (RH5)74611ABD-Lys79967
ANTI-K (KEL1)74711ABDVI-Lys v279990
PHENOKIT74911ABD-Lys v279991
SERA CQI59502HEMALYS 1 A1, B59659
SERA CQI FYA59503HEMALYS 1 A1,A2,B,O59661
ScreenLys79853HEMALYS 1 A1, B59663
ScreenLys 279843HEMASCREEN59852
CrossLys79854HEMA-IDENT59855
ScreenLys Plate79861HEMASCREEN POOL59550
I-Mag Screen59857AGH MEASTRIA C3D76118
I-Mag Ident59859AGH MAESTRIA IGG76218
ABS CQI59507AGH MAESTRIA IGG+C3D76318
ANTI-Jka (JK1)78003ANTI-Jka (JK1) PK73020
ANTI-Jkb (JK2)78004ANTI-Jkb (JK2) PK73021
ANTI-Fya (FY1)78014ANTI-Fya (FY1) PK73022
ANTI-Fyb (FY2)78015ANTI-Fyb (FY2) PK73023
HEMATEST A1, A2, B, O51999NEG CONTROL73026
HEMATEST A1, B58950Qr Anti-D WEAK20401
Qr ANTI-Jka (JK1)20501Qr ANTI-Fya (FY1)20504
Qr ANTI-Jkb (JK2)20503Qr ANTI-Fyb (FY2)20509
Qr NEG CONTROL20507AGH ANTI-IgG PK73028

December 31, 2028 for the following Class C devices:

DESIGNATIONREFDESIGNATIONREF
ANTI-M (MNS1)78005Qr ANTI-S (MNS3)20505
ANTI-N (MNS2)78006Qr ANTI-s (MNS4)20506
ANTI-S (MNS3)78007Qr ANTI-k (KEL2)20508
ANTI-s (MNS4)78008ANTI-S (MNS3) PK73024
ANTI-Lea (LE1)78009ANTI-s (MNS4) PK73025
ANTI-Leb (LE2)78010ANTI-M (MNS1) PK73070
ANTI-P178011ANTI-N (MNS2) PK73071
ANTI-Cw (RH8)78013ANTI-s (MNS4) PK73032
ANTI-k (KEL2)78016

December 31, 2029 for the following Class B devices:

DESIGNATIONREFDESIGNATIONREF
MagneLys79900Qr IRONMAG20000
NanoLys Gel69305DC-Lys79300
I-Mag Diluent69312Blue Control79880

Our class A devices have been CE marked since May 2022 according to European Regulation No. 2017/746.

21 certificates are currently available.
Updated on February 25th, 2026
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
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