Reagena Oy

Finland FI-MF-000002804 Last updated 21 Oct 2026

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Devices: 47
Registries: EUDAMED
FDA recalls: 0

Catalogue47

EUDAMED certificates1

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

Eurofins Electric & Electronics Finland Oy 0537 1 certificate

CR-04-1235-886-25 Issued

Quality management system EU IVDR

Issued
22 Sep 2025

Expires
22 Sep 2030

Notified bodies

Eurofins Electric & Electronics Finland Oy 0537

About

Reagena is an undisputed leader in Hantavirus rapid diagnostics. Reagena offers rapid tests intended for qualitative detection for Puumala virus and Dobrava or Hantaan virus specific IgM antibodies from human serum or plasma. Test results are used as an aid in the diagnosis of acute Hantavirus infections.

From the manufacturer's own website. Source

What Reagena Oy makes

Reagena Oy manufactures staining solutions and kits for microscopic examination, including Giemsa, May-Grünwald, and Weigert-Van Gieson formulations, as well as urine staining reagents. The company also supplies buffered formalin solutions in various volumes for tissue fixation and preservation, used in laboratory sample preparation. Diagnostic products include enzyme immunoassay (EIA) kits for detecting IgG antibodies against Hantavirus serotypes, such as Dobrava and Hantaan.

These products are classified as Class A and Class B medical devices, with some falling under the In Vitro Diagnostic Medical Device (IVD) General category. The company’s devices are registered in the EU’s eudamed database, and the manufacturer is based in Finland.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Finland
Address: 18, Takojantie, Toivala, Finland
Website: www.reagena.com
LinkedIn: linkedin.com/company/reagena
Facebook: facebook.com/reagenaltd
Email: [email protected]
Phone: +358 10 5045 200
PRRC contact: Merja Niemi
EUDAMED SRN: FI-MF-000002804

Catalogue47

Giemsa solution Ref 180119

May-Grünwald solution Ref 180211

Weigert-Van Gieson Staining Kit Ref 102538

Reastain Urine Ref 140345

Etanolifiksatiivi 50 % V/V, sis. eosiinia (84 x 50 ml) Ref 132354L

May-Grünwald solution Ref 190211

Formalin 10 % in sample container (84 x 60 ml), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 132256L

Reageana DOBRAVA-HANTAAN IgG EIA Ref 114302

Formalin 10 % in sample container (2500 ml), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 1Y2256

Formalin 10 % in sample container (500 ml), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 1G2256

Formalin 10 % in sample container (36 x 125 ml), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 152256L

Formalin 10 % in sample container (84 x 100 ml), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 142256L

Formalin 10 % in sample container with spoon (94 x 8 ml), phosphate buffered pH 7.2 incl. 4 % formaldehyde Ref 1S2256L

ReaScan CXCL13 Ref 114253

Formalin 10 % (200 L), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 102256T

ReaScan+ C6 LYME IgG Ref 114313

Etanolifiksatiivi 50 % V/V, sis. eosiinia (120 x 10 ml) Ref 102354A

PEG-ethanol cytology fixative (120 x 10 ml) Ref 105028A

Formalin 10 % (700 L), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 102256C7

Reastain Quick-Diff Kit Ref 102164

Formalin 10 % (1 L), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 182256

Formalin 10 % in sample container (25 x 30 ml), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 122256K

Formalin 10 % in sample container (380 x 10 ml), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 102256L

Formalin 10 % in sample container (120 x 30 ml), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 122256A

ReaScan TBE IgM Ref 114106

ReaScan DOBRAVA-HANTAAN IgM Ref 114102

Formalin 10 % in sample container (1500 ml), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 1X2256

Reagena DOBRAVA-HANTAAN IgM EIA Ref 114202

Formalin 10 % (20 L), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 1U2256

Ethanol fixative 50 % V/V, incl. eosin (120 x 25 ml) Ref 122354A

Formalin 10 % in sample container (94x8 ml, spoon) phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 162256L

ReaScan+ LYME IgM/IgG Combo Ref 115103

Reagena PUUMALA IgM EIA Ref 114201

Formalin 10 % (5 L), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 192256

Reagena POC PUUMALA IgM Ref 114001

Formalin 10 % (10 L), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 112256

Gram Staining Kit Ref 102600

Formalin 10 % (3 L), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 1E2256

Formalin 10 % in sample container (18 x 250 ml), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 1R2256L

PEG-ethanol cytology fixative (120 x 25 ml) Ref 125028A

Mayer's hematoxylin solution Ref 180210

GEWF solution Ref 192448

Formalin 10 % (800 L), phosphate buffered pH 7, 2 incl. 4 % formaldehyde Ref 102256C8

Reagena C6 LYME IgM/IgG EIA Ref 114403

Eosin solution Ref 180072

ReaScan+ PUUMALA IgM Ref 115105

Reagena PUUMALA IgG EIA Ref 114301