Progenika Biopharma, S.A.

Spain ES-MF-000001005 Last updated 8 Jun 2026

Devices: 18
Registries: EUDAMEDGUDID
FDA recalls: 0

Catalogue18

Promonitor CONTROL-IFX Ref 54315C0000

Class B EUDAMED Active
Promonitor-ANTI-ADL Ref 5090230000

Class B EUDAMED Active
Promonitor-ETN Ref 5110230000

IVD General EUDAMED Active
Promonitor-ANTI-GLM Ref 5210230000

IVD General EUDAMED Active
Promonitor-GLM Ref 5200230000

IVD General EUDAMED Active
Promonitor CONTROL-ADL Ref 54415C0000

Class B EUDAMED Active
Promonitor-ANTI-ETN Ref 5120230000

IVD General EUDAMED Active
Promonitor-ANTI-VDZ Ref 5401530000

Class B EUDAMED Active
Promonitor-ANTI-UTK Ref 5381530000

Class B EUDAMED Active
Id Hpa Xt Ref 1010220034

Class C EUDAMED Active
Promonitor-RTX Ref 5130230000

IVD General EUDAMED Active
Promonitor-VDZ Ref 5391530000

Class B EUDAMED Active
Promonitor-ANTI-IFX Ref 5070230000

Class B EUDAMED Active
A1AT Genotyping Test Reagents Ref 1292380000

Class C EUDAMEDFDA UDI Active
Promonitor-ADL Ref 5080230000

Class B EUDAMED Active
Promonitor-IFX Ref 5060230000

Class B EUDAMED Active
Promonitor-UTK Ref 5371530000

Class B EUDAMED Active
Promonitor-ANTI-RTX Ref 5140230000

Class B EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

TÜV SÜD Product Service GmbH 0123 1 certificate

V13 076212 0030 Reissued

Quality management system EU IVDR

Issued
6 Jul 2026

Expires
22 Sep 2031

Valid from
23 Sep 2026

Notified bodies

TÜV SÜD Product Service GmbH 0123

Information

Country: Spain(from SRN)
Address: Ibaizabal bidea, Edificio 504, Derio, Spain
Website: grifols.com
Email: [email protected]
PRRC contact: Jokin Del Amo
EUDAMED SRN: ES-MF-000001005