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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 5 of 5

Device	Model / Reference	Registries	Class	Status
Cievka Nelaton s 2 BO, T, 6, 67mm (Ch 20) x 400 mm	V646606-ND	EUDAMED	Class IIa	Active
Infuzní souprava IS-126T – 62 ShA M	V606126-02M	EUDAMED	Class IIa	Active
Irrigation-Cooling Set	V606138-ND	EUDAMED	Class IIa	Active
Cievka Nelaton s 2 BO, T, 2, 67mm (Ch 8) x 400 mm	V646600-ND	EUDAMED	Class IIa	Active
Cievka rektálna s CO, 6, 67mm (Ch 20) x 200 mm	V646686-ND	EUDAMED	Class IIa	Active
Cévka pro novorozence s nízkou porodní hmotností CN-01 M	V646959-M	EUDAMED	Class IIa	Active
Cievka Tiemann s 2 BO, 2, 67mm (Ch 8) x 400, M	V646665-ND	EUDAMED	Class IIa	Active
Merač žilového tlaku MŽT-01	V646992-ND	EUDAMED	Class I	Active
Zkumavka 15 ccm PP - sterilní	V400941	EUDAMED	IVD General	Active
Rampa 5cestná s BV NO PVC M	V696425-M	EUDAMED	Class IIa	Active
Cievka Nelaton s 2 BO, T, 8, 3mm (Ch 25) x 400 mm	V646609-ND	EUDAMED	Class IIa	Active
LL combo stopper - white NO PVC	Z676006	EUDAMED	Class I	Active
Cievka Nelaton s 2 BO, M, 2, 67mm (Ch 8) x 400 mm	V646610-ND	EUDAMED	Class IIa	Active
Bezihlový vstup	V696420	EUDAMED	Class IIa	Active
GAMAPLUS® 1, 8 x 450 UNIV M	V606306-M	EUDAMED	Class IIa	Active
Infuzní souprava IS-123 M	V606123-M	EUDAMED	Class IIa	Active
Trojcestný kohout – modrý NO PVC M	V696435-M	EUDAMED	Class IIa	Active
Cievka pupočná pre novorodenca CP-01	V646958-ND	EUDAMED	Class IIa	Active
GAMAPLUS 3, 0 x 2500 LL	V606347-ND	EUDAMED	Class IIa	Active
GAMAPLUS 1, 8 x 1800 LLK	V606304-01ND	EUDAMED	Class IIa	Active
Cievka rektálna s CO, 5, 33mm (Ch 16) x 120 mm	V646701-ND	EUDAMED	Class IIa	Active
Cévka pupeční pro novorozence CP-01 M	V646958-M	EUDAMED	Class IIa	Active
Cievka Nelaton s 2 BO, M, 4, 67mm (Ch 14) x 400 mm	V646613-ND	EUDAMED	Class IIa	Active
Cévka rektální s CO 4 mm (Ch 12) x 120 mm M	V646699-M	EUDAMED	Class IIa	Active
Petriho miska Ø 60 mm pro tkáňové kultury	V400928	EUDAMED	IVD General	Active
GAMAPLUS 1, 8 x 450 UNIV	V606306-ND	EUDAMED	Class IIa	Active
GAMAPLUS 1, 8 x 450 LLK	V606301-01ND	EUDAMED	Class IIa	Active
Cievka pre výživu novorodenca CV-01	V646957-ND	EUDAMED	Class IIa	Active
Zkumavka 10 ccm PS - sterilní - zátka 493307	V400914-01	EUDAMED	IVD General	Active
Cievka rektálna s CO, 6, 67mm (Ch 20) x 300 mm	V646687-ND	EUDAMED	Class IIa	Active
Prodlužovací hadička PVC, 50 cm pro světlocitlivé léky M	V686423-02M	EUDAMED	Class IIa	Active
SKALA OK3-V2 Lavážní set M	V606501-02M	EUDAMED	Class IIa	Active
Merač žilového tlaku MŽT-02	V646993-ND	EUDAMED	Class I	Active
Zkumavka 15 ccm PS - sterilní bez zátky	V400526	EUDAMED	IVD General	Active
Cievka Nelaton s 2 BO, M, 6, 67mm (Ch 20) x 400 mm	V646616-ND	EUDAMED	Class IIa	Active
Mikrotitrační destička U	V400916	EUDAMED	Class A	Active
Infuzní souprava IS-126 - 62 ShA M	V606126-01M	EUDAMED	Class IIa	Active
Cievka rektálna s CO, 8, 3mm (Ch 25) x 200 mm	V646704-ND	EUDAMED	Class IIa	Active
Cévka odsávací s CO, 1 BO 6 mm (Ch 18) x 400 mm M	V646744-M	EUDAMED	Class IIa	Active
Predlžovacia hadička PVC, 150 cm	V606502-ND	EUDAMED	Class IIa	Active
Cievka rektálna s CO, 4, 67mm (Ch 14) x 120 mm	V646700-ND	EUDAMED	Class IIa	Active
GAMAPLUS® 3, 0 x 150 LCH M	V606372-M	EUDAMED	Class IIa	Active
Transfúzna súprava TS-204	V606204-ND	EUDAMED	Class IIa	Active
Cévka rektální s CO 6, 67 mm (Ch 20) x 300 mm M	V646687-M	EUDAMED	Class IIa	Active
Cievka Nelaton s 2 BO, T, 4, 67mm (Ch 14) x 400 mm	V646603-ND	EUDAMED	Class IIa	Active

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