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GAMA GROUP a.s.

Czechia·CZ-MF-000011894

Last updated September 17, 2026

What GAMA GROUP a.s. makes

The company manufactures medical devices for fluid management, including transfusion sets like the TS-203 and infusion sets such as the IS-123, designed for intravenous administration. It also produces drainage tubes for various applications, such as endobronchial (CE-600) and rectal (14 Ch x 120 mm) use, as well as connecting hoses and perfusion sets like the SKALA OK3-V1. Three-way ramps and suction catheters with different lumen configurations are part of its portfolio, alongside specialized tubing for medical procedures.

These devices fall under EU regulatory classifications including Class A, Class I, Class IIa, and In Vitro Diagnostic (IVD) General, with listings maintained in the EUDAMED database. The manufacturer operates from the Czech Republic and adheres to EU medical device regulations, ensuring compliance with relevant standards for market placement.

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

Information

Country: Czechia
Address: 11/3b, Mánesova, České Budějovice, Czechia
Website: gama.cz
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Hana Mašlaňová
EUDAMED SRN: CZ-MF-000011894
FDA FEI Number: —
DUNS Number: —

Catalogue (245)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
SKALA OK3 Perfusion set	V606501	EUDAMED	Class IIa	Active
Cévka odsávací s CO, 1 BO 5, 33 mm (Ch 16) x 400 mm M	V646743-M	EUDAMED	Class IIa	Active
Cievka rektálna s CO, 10mm (Ch 30) x 400 mm	V646698-ND	EUDAMED	Class IIa	Active
Cévka rektální s CO 10 mm (Ch 30) x 400 mm M	V646698-M	EUDAMED	Class IIa	Active
Infúzna súprava IS-126 180 cm - 62 ShA	V606129-01ND	EUDAMED	Class IIa	Active
Cévka rektální s CO 8, 3 mm (Ch 25) x 400 mm M	V646706-M	EUDAMED	Class IIa	Active
Priming set dialyzačních souprav PS 003 M	V606003-M	EUDAMED	Class IIa	Active
GAMAPLUS 3, 0 x 150 LL	V606321-ND	EUDAMED	Class IIa	Active
Infuzní souprava IS-127 P® M	V606127-M	EUDAMED	Class IIa	Active
Láhev na moč s uzávěrem v PE sáčku	V204811-02	EUDAMED	Class I	Active
Cievka pre zavádzanie kyslíka nosovou cestou CK-472	V646956-ND	EUDAMED	Class I	Active
Zkumavka 10 ccm PS - sterilní bez zátky	V400523	EUDAMED	IVD General	Active
Rampa 5 kohoutů NO PVC M	V696437-M	EUDAMED	Class IIa	Active
Kónická odměrka na moč 250 ml - modrá	V204809-55	EUDAMED	Class A	Active
Irigačný Set	V606135-ND	EUDAMED	Class IIa	Active
Kónická odměrka na moč 100 ml - zelená	V204808-54	EUDAMED	Class A	Active
Cévka rektální s CO 6 mm (Ch 18) x 120 mm M	V646702-M	EUDAMED	Class IIa	Active
Spojovací hadička 2-cestná M	V606402-M	EUDAMED	Class IIa	Active
Reverzačný set	V606136-ND	EUDAMED	Class IIa	Active
GAMAPLUS 1, 8 x 1800 UNIV	V606307-ND	EUDAMED	Class IIa	Active
Urodynamická souprava malá USM M	V606481-M	EUDAMED	Class IIa	Active
Cévka pro novorozence CN-01 100 cm M	V686417-01M	EUDAMED	Class IIa	Active
Petriho miska Ø 90 mm sterilní - R - EN	V400994-EN	EUDAMED	IVD General	Active
Trojcestný kohút - biely NO PVC	V696442	EUDAMED	Class IIa	Active
GAMAPLUS® 1, 8 x 1800 LLK M	V606304-01M	EUDAMED	Class IIa	Active
Cievka odsávacia s CO, 1 BO, 2, 67mm (Ch 8) x 400 mm	V646739-ND	EUDAMED	Class IIa	Active
Petriho miska Ø 90 mm - sterilní EO	V400995	EUDAMED	IVD General	Active
Cévka pro výživu novorozence CV-01 M	V646957-M	EUDAMED	Class IIa	Active
SKALA OK3-V2 Perfusion set	V606501-02	EUDAMED	Class IIa	Active
Petriho miska Ø 90 mm s neprůhledným víčkem	V400902	EUDAMED	Class A	Active
Kónická odměrka na moč 250 ml - zelená	V204809-54	EUDAMED	Class A	Active
GAMAPLUS® 1, 8 x 1500 LL M	V606303-M	EUDAMED	Class IIa	Active
Cievka odsávacia s CO, 1 BO, 4mm (Ch 12) x 400 mm	V646741-ND	EUDAMED	Class IIa	Active
Mikrotitrační destička dělená P - jednostrip	V400933	EUDAMED	Class A	Active
Cievka rektálna s CO, 10mm (Ch 30) x 300 mm	V646697-ND	EUDAMED	Class IIa	Active
Transfuzní souprava TS-204 M	V606204-M	EUDAMED	Class IIa	Active
GAMAPLUS 4, 5 x 20 LCH	V606372-01ND	EUDAMED	Class IIa	Active
Urodynamická souprava malá USM - 1845 mm M	V606481-02M	EUDAMED	Class IIa	Active
Cévka odsávací s CO, 1 BO 6, 67 mm (Ch 20) x 400 mm M	V646745-M	EUDAMED	Class IIa	Active
Zkumavka 10 ccm PS - sterilní	V400914	EUDAMED	IVD General	Active
Infúzna súprava IS-103	V606103-ND	EUDAMED	Class I	Active
Cievka Redon 28 otvorov, 4, 67mm (Ch 14) x 1200 mm	V646631-ND	EUDAMED	Class IIa	Active
Prodlužovací hadička PVC, 150 cm M	V606502-M	EUDAMED	Class IIa	Active
Cievka Nelaton s 2 BO, M, 6mm (Ch 18) x 400 mm	V646615-ND	EUDAMED	Class IIa	Active
Kónická odměrka na moč 100 ml - žlutá	V204808-53	EUDAMED	Class A	Active
Infúzna súprava IS-127 P 180 cm	V606128-ND	EUDAMED	Class IIa	Active
Petriho miska Ø 90 mm - sterilní R	V400994	EUDAMED	IVD General	Active
Trojcestný kohút - modrý NO PVC	V696435	EUDAMED	Class IIa	Active
Cévka endobronchiální CE-600 M	V606452-M	EUDAMED	Class IIa	Active
Cievka rektálna s CO, 8, 3mm (Ch 25) x 150 mm	V646703-ND	EUDAMED	Class IIa	Active

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