Statistics for Immunolab Ltd.

381Total Devices

5Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for Immunolab Ltd.

No certificates registered for this manufacturer.

Devices by risk class

Device catalog for Immunolab Ltd.

Showing 251–275 of 381 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Salmonella Antiserum O:13,22 - 1ml	`SS020`	`05905753740799`	1	On the market
Salmonella Antiserum O:13,22 - 2ml	`WS020`	`05905753740782`	1	On the market
Salmonella Antiserum O:13,22 - 3ml	`SX020`	`05905753740775`	1	On the market
Salmonella Antiserum O:13,22 - 5ml	`S020`	`05905753740768`	1	On the market
Salmonella Antiserum O:13,23 - 2ml	`WS021`	`05905753740829`	1	On the market
Salmonella Antiserum O:13,23 - 3ml	`SX021`	`05905753740812`	1	On the market
Salmonella Antiserum O:13,23- 1ml	`W0104080301`	`05905753740836`	1	On the market
Salmonella Antiserum O:13/O:G - 1ml	`SS032`	`05905753740751`	1	On the market
Salmonella Antiserum O:13/O:G - 3ml	`WS032`	`05905753740744`	1	On the market
Salmonella Antiserum O:13/O:G - 3ml	`SX032`	`05905753740737`	1	On the market
Salmonella Antiserum O:13/O:G - 5ml	`S032`	`05905753740720`	1	On the market
Salmonella Antiserum O:14/O:H - 1ml	`SS033`	`05905753740874`	1	On the market
Salmonella Antiserum O:14/O:H - 3ml	`SX033`	`05905753740850`	1	On the market
Salmonella Antiserum O:14/O:H - 5ml	`S033`	`05905753740843`	1	On the market
Salmonella Antiserum O:14/OH - 2ml	`WS033`	`05905753740867`	1	On the market
Salmonella Antiserum O:15 - 1ml	`SS016`	`05905753740911`	1	On the market
Salmonella Antiserum O:15 - 2ml	`WS016`	`05905753740904`	1	On the market
Salmonella Antiserum O:15 - 5ml	`S016`	`05905753740881`	1	On the market
Salmonella Antiserum O:15- 3ml	`SX016`	`05905753740898`	1	On the market
Salmonella Antiserum O:18 - 1ml	`SS022`	`05905753740959`	1	On the market
Salmonella Antiserum O:18 - 2ml	`WS022`	`05905753740942`	1	On the market
Salmonella Antiserum O:18 - 3ml	`SX022`	`05905753740935`	1	On the market
Salmonella Antiserum O:18 - 5ml	`S022`	`05905753740928`	1	On the market
Salmonella Antiserum O:19 - 1ml	`SS017`	`05905753740997`	1	On the market
Salmonella Antiserum O:19 - 2ml	`WS017`	`05905753740980`	1	On the market

9 10 11 12 13

Device families (Basic UDI-DI) of Immunolab Ltd.

Showing 1–5 of 5 device families.

Antiserum for slide agglutination of Salmonella590575374SAL001E4
Rabbit coagulase plasma (lyophilized)590575374OSO002KD
SIT EnTy Kit Quick Identification Test for in vitro diagnostic of Salmonella Enteritidis and Typhimurium strains 590575374PS004F6
SIT OH-Sal Kit Quick Identification Test for in vitro diagnostic of Salmonella spp.590575374PS006FA
SIT InHaVi Kit Quick Identification Test for in vitro diagnostic of Salmonella Infantis, Hadar i Virchow strains590575374PS005F8

Market presence of Immunolab Ltd.

Devices placed in 1 country

Poland381

EUDAMED update: Jun 28, 2024

Research and Development Department Of Salmonella Center IMMUNOLAB Ltd.

PL-MF-000042563

Active

Address: Kładki, 24 80-822 Gdańsk
Role: Manufacturer
Date of registration: Jun 13, 2024
Country: PL Poland

About Immunolab Ltd.

SRN: PL-MF-000042563
Role: Manufacturer
Country: Poland
Organization name: Zakład Badawczo-Wdrożeniowy Ośrodka Salmonella "IMMUNOLAB" Sp. z o. o.
EU VAT number: PL5862011240
EORI: PL586201124000000
Trade register: 0000098932
Date of registration: Jun 13, 2024

Contact details for Immunolab Ltd.

Address: 24, KŁADKI 80-822 GDAŃSK POLAND
Phone: +48 58 781 44 91
Email: info@immunolab.com.pl
Website: https://immunolab.com.pl/

Validator

Name: Urząd Rejestracji Produktów Leczniczych
SRN: PL-CA-014
Phone: +48 22 492 11 71
Email: wm@urpl.gov.pl

Officers and regulatory representatives of Immunolab Ltd.

LIEDER Dorota
Responsible for ensuring that: -the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; -the post-market surveillance obligations are complied with in accordance with Article 10(9) of IVDR
Hidden
KOŚCIUK Aleksandra
Responsible for ensuring that: -the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; -the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; -the post-market surveillance obligations are complied with in accordance with Article 10(9) of IVDR
Hidden
TARSALEWSKA Karolina
Responsible for ensuring that: -the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; -the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; -the post-market surveillance obligations are complied with in accordance with Article 10(9) of IVDR
Hidden

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