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Biotem Co., ltd

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000040891

Devices
1,418
Registrations
EUDAMEDFDA
FDA recalls
0

Catalogue1,418

Newest first, page 14 of 29

  • PXFI4110S Ref PXFI4110S

    Class IIb EUDAMED Active

  • FXBR4018RS Ref FXBR4018RS

    Class IIb EUDAMED Active

  • FXIR4510MS Ref FXIR4510MS

    Class IIb EUDAMED Active

  • SAAT30545MN Ref SAAT30545MN

    Class IIb EUDAMED Active

  • SAAS65757 Ref SAAS65757

    Class IIb EUDAMED Active

  • FXBR4008TS Ref FXBR4008TS

    Class IIb EUDAMED Active

  • FXAR5013TS Ref FXAR5013TS

    Class IIb EUDAMED Active

  • SAAT30627M Ref SAAT30627M

    Class IIb EUDAMED Active

  • ASTFA4008S Ref ASTFA4008S

    Class IIb EUDAMED Active

  • ASTFA3515S Ref ASTFA3515S

    Class IIb EUDAMED Active

  • SIC4804S Ref SIC4804S

    Class IIb EUDAMED Active

  • HAA405M Ref HAA405M

    Class IIb EUDAMED Active

  • HAA703T Ref HAA703T

    Class IIb EUDAMED Active

  • SAAT30615MN Ref SAAT30615MN

    Class IIb EUDAMED Active

  • HAB41607 Ref HAB41607

    Class IIb EUDAMED Active

  • MAA552 Ref MAA552

    Class IIb EUDAMED Active

  • SAAT40524 Ref SAAT40524

    Class IIb EUDAMED Active

  • SAAS40517 Ref SAAS40517

    Class IIb EUDAMED Active

  • HAA505T Ref HAA505T

    Class IIb EUDAMED Active

  • ASTFA4010S Ref ASTFA4010S

    Class IIb EUDAMED Active

  • FXIR4813WS Ref FXIR4813WS

    Class IIb EUDAMED Active

  • SAAT30645MN Ref SAAT30645MN

    Class IIb EUDAMED Active

  • FXBR3718RS Ref FXBR3718RS

    Class IIb EUDAMED Active

  • HAI554 Ref HAI554

    Class IIb EUDAMED Active

  • FXBR5007TS Ref FXBR5007TS

    Class IIb EUDAMED Active

  • HAI35503 Ref HAI35503

    Class IIb EUDAMED Active

  • FXAR6007TS Ref FXAR6007TS

    Class IIb EUDAMED Active

  • SAAS30525M Ref SAAS30525M

    Class IIb EUDAMED Active

  • FXBR3313RS Ref FXBR3313RS

    Class IIb EUDAMED Active

  • FXBR5015TS Ref FXBR5015TS

    Class IIb EUDAMED Active

  • FXAR4008TS Ref FXAR4008TS

    Class IIb EUDAMED Active

  • HAA502T Ref HAA502T

    Class IIb EUDAMED Active

  • FXBR5013RS Ref FXBR5013RS

    Class IIb EUDAMED Active

  • FXBR3307TS Ref FXBR3307TS

    Class IIb EUDAMED Active

  • OAO553M Ref OAO553M

    Class IIb EUDAMED Active

  • AO727T Ref AO727T

    Class IIb EUDAMED Active

  • FXAR6011TS Ref FXAR6011TS

    Class IIb EUDAMED Active

  • SAAT30525MN Ref SAAT30525MN

    Class IIb EUDAMED Active

  • FXBR4515RS Ref FXBR4515RS

    Class IIb EUDAMED Active

  • FXTR5010RS Ref FXTR5010RS

    Class IIb EUDAMED Active

  • FXBR3311RS Ref FXBR3311RS

    Class IIb EUDAMED Active

  • OAO559M Ref OAO559M

    Class IIb EUDAMED Active

  • SAAS50634 Ref SAAS50634

    Class IIb EUDAMED Active

  • FXAR3411TS Ref FXAR3411TS

    Class IIb EUDAMED Active

  • FXIR4511MS Ref FXIR4511MS

    Class IIb EUDAMED Active

  • FXTR6011TS Ref FXTR6011TS

    Class IIb EUDAMED Active

  • FXBR3708TS Ref FXBR3708TS

    Class IIb EUDAMED Active

  • FXAR4507TS Ref FXAR4507TS

    Class IIb EUDAMED Active

  • SAAS40524 Ref SAAS40524

    Class IIb EUDAMED Active

  • FXBR6010RSS Ref FXBR6010RSS

    Class IIb EUDAMED Active

Showing 651-700 of 1,418

Company details

EUDAMED SRN
KR-MF-000040891
DUNS number
557793214
EU VAT number
606-86-11968
EUDAMED status
Active
EUDAMED registered name
Biotem Co., Ltd.
Registered address
422, Sasang-ro, 46925, Busan, South Korea
PRRC contact
Chang Kyu Hwang(public in EUDAMED)

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Biotem Co., Ltd. Busan · KR FEI 3009611645

What Biotem Co., ltd makes

Biotem Co., Ltd manufactures dental implant systems, including components designed for osseointegration in oral and maxillofacial applications. Their portfolio also includes bone pins, which are used for internal fixation in surgical procedures. The devices are intended for use in dental and orthopedic settings, supporting structural stability and integration with bone tissue.

The company’s products are regulated under the FDA’s classification system, with devices falling into Class I and Class II categories. These are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.