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B&E KOREA Co., Ltd.

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000030252 FEI 3032435508

Devices
29
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI

Catalogue29

Newest first, rows 1-29 of 29

Search and filter all 29 devices
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  • Xs-FiL AO2 Ref #1111AO2

    Class IIa
    Active CE MDR EUDAMED IIa

  • ChemiTemp NE Ref #212100

    Class IIa
    Active CE MDR EUDAMED IIa

  • Xs-FiL AO3 Ref #1111AO3

    Class IIa
    Active CE MDR EUDAMED IIa

  • ChemiTemp Orange Ref #212200

    Class IIa
    Active CE MDR EUDAMED IIa

  • Xs-FiL B2 Ref #1111B2

    Class IIa
    Active CE MDR EUDAMED IIa

  • Chemi-SiL Bite-Blu Ref #513100

    Class I
    Active CE MDR EUDAMED I

  • ChemiCore White Ref #1161WH

    Class IIa
    Active CE MDR EUDAMED IIa

  • Chemi-SiL HB Ref #511100

    Class I
    Active CE MDR EUDAMED I

  • B&E Flow A3.5 Ref #1121A35

    Class IIa
    Active CE MDR EUDAMED IIa

  • Chemi-SiL LB Ref #512100

    Class I
    Active CE MDR EUDAMED I

  • Xs-FiL B1 Ref #1111B1

    Class IIa
    Active CE MDR EUDAMED IIa

  • Xs-FiL A2 Ref #1111A2

    Class IIa
    Active CE MDR EUDAMED IIa

  • B&E Flow A3 Ref #1121A3

    Class IIa
    Active CE MDR EUDAMED IIa

  • B&E Etch-37 Ref #115100

    Class IIa
    Active CE MDR EUDAMED IIa

  • CEM Universal Ref #000109

    Class IIa
    Active CE MDR EUDAMED IIa

  • B&E Flow A1 Ref #1121A1

    Class IIa
    Active CE MDR EUDAMED IIa

  • Xs-FiL A3 Ref #1111A3

    Class IIa
    Active CE MDR EUDAMED IIa

  • X-Temp Yellow Ref #2131YL

    Class IIa
    Active CE MDR EUDAMED IIa

  • ChemiCore A3 Ref #1161A3

    Class IIa
    Active CE MDR EUDAMED IIa

  • Cement Blu Ref #000104

    Class IIa
    Active CE MDR EUDAMED IIa

  • Bond T Ref #411100

    Class IIa
    Active CE MDR EUDAMED IIa

  • CEM Implant Ref #211100

    Class IIa
    Active CE MDR EUDAMED IIa

  • Xs-FiL A3.5 Ref #1111A35

    Class IIa
    Active CE MDR EUDAMED IIa

  • B&E Flow B2 Ref #1121B2

    Class IIa
    Active CE MDR EUDAMED IIa

  • B&E Temp Yellow Ref #2132YL

    Class IIa
    Active CE MDR EUDAMED IIa

  • Xs-FiL A1 Ref #1111A1

    Class IIa
    Active CE MDR EUDAMED IIa

  • B&E Flow A2 Ref #1121A2

    Class IIa
    Active CE MDR EUDAMED IIa

  • Chemi-SiL Clear Ref #214100

    Class I
    Active CE MDR EUDAMED I

  • Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu Ref K233954

    Class II
    Active 510(k) 510(k) II

Rows 1-29 of 29

Company details

EUDAMED SRN
KR-MF-000030252
FDA FEI number
3032435508
EUDAMED status
Active
EUDAMED registered name
B&E KOREA Co., Ltd.
Registered address
995-16, Baran-ro, 18515, Hwaseong-si, South Korea
PRRC contact
Jayong Shin(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 15 Mar 2031

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HZ 2026141-1 Issued

    Quality management system EU MDR

    Issued
    16 Mar 2026
    Expires
    15 Mar 2031

Frequently asked questions

How many devices does B&E KOREA Co., Ltd. have in the registry?

The registry currently lists 29 devices for B&E KOREA Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list B&E KOREA Co., Ltd.'s devices?

Among its 29 most recently registered devices, B&E KOREA Co., Ltd. has devices listed in EUDAMED (28 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do B&E KOREA Co., Ltd.'s devices fall under?

Among its 29 most recently registered devices, the classes recorded for B&E KOREA Co., Ltd.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for B&E KOREA Co., Ltd.?

EUDAMED lists 1 certificate for B&E KOREA Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-03-16.

What are the newest devices from B&E KOREA Co., Ltd. in the registry?

The most recently registered devices listed for B&E KOREA Co., Ltd. include Xs-FiL AO2, ChemiTemp NE, Xs-FiL AO3 and ChemiTemp Orange.

Generated automatically from registry data and not verified by a human reviewer.