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BioMaterials Korea, Inc.

South Korea·KR-MF-000019882

Last updated June 8, 2026

Information

Country: South Korea
Address: 150, Jojeong-daero, Hanam-si, Gyeonggi-do, South Korea
Website: biomk.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Hyungmin Shim
EUDAMED SRN: KR-MF-000019882
FDA FEI Number: —
DUNS Number: —

Catalogue (98)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Blade for CMF Surgery	SEB-20SQ	EUDAMED	Class I	Active
Blade for CMF Surgery	SEB-23C	EUDAMED	Class I	Active
Short Engine Blade	SEBC-HP	EUDAMED	Class I	Active
Blade for CMF Surgery	LEB-23C	EUDAMED	Class I	Active
Long Engine Blade	LEBC-HP	EUDAMED	Class I	Active
Maxillary Skeletal Expander	KBE Ⅱ-6-001	EUDAMED	Class IIa	Active
Maxillary Skeletal Expander	MSE Ⅱ-6 F-001	EUDAMED	Class IIa	Active
Handle	SDH4-A	EUDAMED	Class I	Active
Maxillary Skeletal Expander	MSE Ⅱ-8 F-001	EUDAMED	Class IIa	Active
Bone Plate; Bone Screw	K110926	FDA 510(k)	Class II	Active
ACR Screw System	K222245	FDA 510(k)	Class II	Active
Anchor plate	K173623	FDA 510(k)	Class II	Active
C Type, Ct Type, And Special Type Orthodontic Anchor Screws	K063495	FDA 510(k)	Class II	Active
Sl Type Orthodontic Anchor Screws, Spl Type Orthodontic Anchor Screws	K111809	FDA 510(k)	Class II	Active
Orthodontic Anchor Screw	OAS-T1511S-001	EUDAMED	Class IIb	Active
Orthodontic Anchor Screw	SL-U2-001	EUDAMED	Class IIb	Active
Orthodontic Anchor Screw	Orthoplant2505SH-001	EUDAMED	Class IIb	Active
Long Engine Blade	LEB-U(BS)	EUDAMED	Class I	Active
Orthodontic Anchor Screw	Mplant-U2-LN-001	EUDAMED	Class IIb	Active
Orthodontic Anchor Screw	SPL-1507-001	EUDAMED	Class IIb	Active
Driver Blade	SDBO	EUDAMED	Class I	Active
Handle	MHD-SMS	EUDAMED	Class I	Active
Maxillary Skeletal Expander	RPE-8-001	EUDAMED	Class IIa	Active
Orthodontic Anchor Screw	OAS-T1817-001	EUDAMED	Class IIb	Active
Orthodontic Anchor Screw	OAS-T1509-001	EUDAMED	Class IIb	Active
Maxillary Skeletal Expander	KBE-6-001	EUDAMED	Class IIa	Active
Maxillary Skeletal Expander	KBE-12-001	EUDAMED	Class IIa	Active
Orthodontic Anchor Screw	SPL-1509H-001	EUDAMED	Class IIb	Active
Blade for CMF Surgery	SDB-15C-75	EUDAMED	Class I	Active
Orthodontic Anchor Screw	SL-U3-07-001	EUDAMED	Class IIb	Active
Long Engine Blade	LEBO	EUDAMED	Class I	Active
Orthodontic Anchor Screw	Orthoplant-MP-001	EUDAMED	Class IIb	Active
Orthodontic Anchor Screw	SMS-9-001	EUDAMED	Class IIb	Active
Orthodontic Anchor Screw	OAS-T1813-001	EUDAMED	Class IIb	Active
Handle	MHDO	EUDAMED	Class I	Active
Long Engine Blade	LEB-SL	EUDAMED	Class I	Active
Maxillary skeletal expander	MSE-6-001	EUDAMED	Class IIa	Active
Orthodontic Anchor Screw	Caplant07CW-001	EUDAMED	Class IIb	Active
Orthodontic Anchor Screw	OAS-T1375-001	EUDAMED	Class IIb	Active
Driver Blade	SDB-15C	EUDAMED	Class I	Active
Orthodontic Anchor Screw	Mplant-L1	EUDAMED	Class IIb	Active
Short Engine Blade	SEB-SMS	EUDAMED	Class I	Active
Orthodontic Anchor Screw	OAS-T1811-001	EUDAMED	Class IIb	Active
Maxillary Skeletal Expander	RPE-6-001	EUDAMED	Class IIa	Active
Orthodontic Anchor Screw	OAS-T1207-001	EUDAMED	Class IIa	Active
Orthodontic Anchor Screw	Orthoplant2505H-001	EUDAMED	Class IIb	Active
Orthodontic Anchor Screw	OAS-T1511-001	EUDAMED	Class IIb	Active
Maxillary Skeletal Expander	MSE Ⅱ-10 E-001	EUDAMED	Class IIa	Active
Blade	SDB15	EUDAMED	Class I	Active
Driver Blade	SDBO-MP	EUDAMED	Class I	Active

Related Companies

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KTR Europe GmbH DE

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