Question 1

What types of medical devices does UAB 'Medicinos linija' manufacture?

Accepted Answer

UAB 'Medicinos linija' specializes in dental materials, including etching gels (such as elitis etch and UNODENT etch gel), light-curing composites (like G-DENT Nano Hybrid Composite and i-XCITE LC N), dental cements (VIDU DUAL RESIN CEMENT), dental sealants (i-GEL N and i-SEAL LC), compomer liners (dline Light Curing Compomer Liner), and dental adhesives. These products are designed for clinical use in dental procedures.

Question 2

Where is UAB 'Medicinos linija' based, and how does that affect its regulatory standing?

Accepted Answer

UAB 'Medicinos linija' is based in Lithuania, which is part of the European Union. This location allows its devices to be registered and monitored through EU regulatory frameworks, such as the EUDAMED database, ensuring compliance with EU medical device regulations.

Question 3

Which EU registries list the devices manufactured by UAB 'Medicinos linija'?

Accepted Answer

The devices produced by UAB 'Medicinos linija' are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry tracks device information, including manufacturer details, classifications, and regulatory status, ensuring transparency and compliance with EU medical device regulations.

Question 4

How are the devices from UAB 'Medicinos linija' classified under EU regulations?

Accepted Answer

The devices manufactured by UAB 'Medicinos linija' are classified as either Class I or Class IIa medical devices under EU regulations. This classification is determined by factors such as the intended use, duration of contact with the body, and potential risks associated with the device, ensuring appropriate regulatory oversight and compliance requirements.

Device	Model / Reference	Registries	Class	Status
elitis etch	QMSIGE3	EUDAMED	Class IIa	Active
i-GEL N	IGE50G	EUDAMED	Class IIa	Active
UNODENT etch gel	FBG701	EUDAMED	Class IIa	Active
Elitis etch	QMSIGECP	EUDAMED	Class IIa	Active
i-GEL N	IGE12B	EUDAMED	Class IIa	Active
Elitis etch	PDPS24	EUDAMED	Class IIa	Active
i-GEL N	IGEK3	EUDAMED	Class IIa	Active
G-DENT Nano Hybrid Composite	GDNHC02	EUDAMED	Class IIa	Active
i-SEAL LC	ISEKM	EUDAMED	Class IIa	Active
dline Light Curing Compomer Liner	12010	EUDAMED	Class IIa	Active
Vidu Dual Resin Cement	VI93500	EUDAMED	Class IIa	Active
i-XCITE LC N	IXTSA3	EUDAMED	Class IIa	Active
I-Faste	IFMD1	EUDAMED	Class I	Active
Alganol Complete	LAB164	EUDAMED	Class IIa	Active
i-ZOE M	IZMP1	EUDAMED	Class IIa	Active
dline Light Curing Zirconium Reinforced Composite	10750	EUDAMED	Class IIa	Active
i-LIGHT N	ILCB2	EUDAMED	Class IIa	Active
i-OIL Plus	IHSOP	EUDAMED	Class I	Active
G-DENT C Plast Kit	GDMPK1	EUDAMED	Class I	Active
dline Knitted Retraction Cord	24020	EUDAMED	Class I	Active
VIDU NANO Composite	VI92204	EUDAMED	Class IIa	Active
i-ZOE M	IZML1	EUDAMED	Class IIa	Active
dline Light Curing Zirconium Reinforced Composite	10860	EUDAMED	Class IIa	Active
I-Faste	IFFD1	EUDAMED	Class I	Active
elitis etch	PDPS24	EUDAMED	Class IIa	Active
i-GEL N	IGES2	EUDAMED	Class IIa	Active
i-DAM	IDAM1	EUDAMED	Class I	Active
dline Glass Ionomer Filling Cement	16020	EUDAMED	Class IIa	Active
Axel	CFC611205	EUDAMED	Class IIa	Active
dline Light curing nano hybrid composite based on zirconium	09320S	EUDAMED	Class IIa	Active
dline Zinc Oxide Eugenol Cement	17410	EUDAMED	Class IIa	Active
OCTACID Green	04-071	EUDAMED	Class IIa	Active
Hatem	CFC611242	EUDAMED	Class IIa	Active
dline C-Silicone Impression Mini Kit	24260	EUDAMED	Class I	Active
Zonalin Complete	LAB002	EUDAMED	Class IIa	Active
DLINE "Light body C-Silicone"	24220	EUDAMED	Class I	Active
I-Faste	IFMBS2	EUDAMED	Class I	Active
i-ROCK	IROA2	EUDAMED	Class IIa	Active
i-EDTA Solution	IED250	EUDAMED	Class IIa	Active
i-FLOW N	IFSA3	EUDAMED	Class IIa	Active
One-Dam	DRMIDABP	EUDAMED	Class I	Active
Nord FLOW	NRDFLA35	EUDAMED	Class IIa	Active
dline Phosphoric Acid Etching Liquid	20900	EUDAMED	Class IIa	Active
G-DENT Dual Cem	GDDC01	EUDAMED	Class IIa	Active
VIDU Etchigg Gel	VI91014	EUDAMED	Class IIa	Active
VIDU Temporary Filling Material	VI93002	EUDAMED	Class IIa	Active
i-FASTE	IFMS2	EUDAMED	Class I	Active
Elegance Flow	ML64404E	EUDAMED	Class IIa	Active
G-DENT C Plast Putty	GDIMP1	EUDAMED	Class I	Active
i-PAK	IPU02	EUDAMED	Class I	Active

UAB "Medicinos linija"

About

What UAB "Medicinos linija" makes

Frequently asked questions

Information

Catalogue (352)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities