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Plasmapp Co., Ltd.

South Korea·KR-MF-000012193

Last updated September 17, 2026

Information

Country: South Korea
Address: 102, Cheombok-ro, Daegu, South Korea
Website: www.plasmapp.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82 1544 0508
PRRC Contact: Juhyung Lee
EUDAMED SRN: KR-MF-000012193
FDA FEI Number: 3016075971
DUNS Number: 695798956

Catalogue (26)

Device	Model / Reference	Registries	Class	Status
Sterilink™	110V	FDA UDI	Class II	Unknown
Sterlink™	BT96	FDA UDI	Class II	Active
Sterlink™	Mini-bio	FDA UDI	Class II	Active
Sterilink™	110V	FDA UDI	Class II	Active
Sterlink™	CD42	FDA UDI	Class II	Active
Sterlink™	STERLOAD	EUDAMEDFDA UDI	Class II	Active
Sterlink™	FPS-15s Plus	FDA UDI	Class II	Unknown
Sterilink™	110V	FDA UDI	Class II	Active
Sterlink™	CT40	FDA UDI	Class II	Active
Sterlink™	FR400100	FDA UDI	Class II	Active
Actilink™	ACTILINK mini	FDA UDI	Class I	Active
Actilink Ex	MD2-0115-00	EUDAMED	Class I	Active
ACTILINK motion	ACTILINK	EUDAMED	Class I	Active
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)	K220345	FDA 510(k)	Class II	Active
Tyvek Roll with CI for STERLINK Sterilizer	K223025	FDA 510(k)	Class II	Active
Tyvek(R) Roll with CI for STERLINKTM Sterilizer	K212198	FDA 510(k)	Class II	Active
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)	K223023	FDA 510(k)	Class II	Active
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)	K212193	FDA 510(k)	Class II	Active
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette	K212200	FDA 510(k)	Class II	Active
STERLINK plus	STERLINK	EUDAMEDFDA 510(k)	Class IIb	Active
Sterlink	STERLINK	EUDAMEDFDA 510(k)	Class IIb	Active
Plasma Ex	MD2-0117-00	EUDAMED	Class I	Active
STERLINK mini	STERLINK	EUDAMED	Class IIb	Active
Plasma Active	MD2-0115	EUDAMED	Class I	Active
ACTILINK reborn	MD2-0069-00	EUDAMEDFDA UDI	Class I	Active
Stermate	STERMATE	EUDAMED	Class IIb	Active

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