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B&L Biotech

Active in EUDAMED
Also registered as B&L BIOTECH CO., INC

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000023296

B&L Biotech is a medical device manufacturer based in South Korea, with 217 devices listed in EUDAMED and FDA GUDID (EU Class I and IIa) as of 15 Nov 2026.

Devices
217
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • EUDAMED 217
  • FDA GUDID 202

A device listed in two registries counts in both.

Device classes
  • EU Class I 157
  • EU Class IIa 60
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN KR-MF-000023296

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment
Authorised rep.
Emergo Europe B.V.NL

What B&L Biotech makes

B&L Biotech manufactures surgical instruments and endoscopic devices, including disposable and reusable single-use products like surgical probes (SPRDS, SPRDN), endoscopic biopsy needles (IS TIP, JETIP), and endoscopic forceps (Endo B). Their portfolio also includes specialized medical tools such as the Leetrac, a surgical retractor, and the POMO, a laparoscopic instrument. Additional offerings include the BSN2123, BSN2225, BMN2425, and BP6012, which appear to serve roles in minimally invasive procedures and tissue manipulation.

The company’s devices are classified under EU Medical Device Regulations as Class I and Class IIa, with listings maintained in the EU’s eudamed registry. Their products are designed for compliance with European Union medical device directives and standards. The manufacturer is based in South Korea.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue217

Newest first, rows 1-50 of 217

Search and filter all 217 devices
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  • Sprds

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

  • Sprdn

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:IIa

  • Leetrac

    Active Regimes: CE MDR CE MDD Registry: EUDAMED Class:I

  • Leetrac

    Active Regimes: CE MDD Registry: EUDAMED Class:I

  • BSN2123

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • BMN2425

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • BSN2225

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Is Tip

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Pomo

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

  • Endo B

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • BP6012

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Jetip

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • BSN2225

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • BSN2425

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • JETIP Instruments Micro Mirror

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • BMN2425

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Kimtrac

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

  • Endo B

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • BP4004

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • JETIP Instruments

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

  • Is Tip

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Beta Mini

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Bl Tip

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • BMN2423

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • BL-S Kondenser

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

  • BSN2420

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • JETIP Instruments

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

  • JETIP Instruments

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:I

  • BMN2420

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Kimtrac

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

  • BSN2820

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Jetip

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Endo R

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

  • BL-S Kondenser

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Como

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Endo M&R

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:I

  • B&L GP Gauge&Cutter Ref GGAC

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Kimtrac

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

  • BL-B Kondenser

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • BP5506

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • JETIP Instruments

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

  • Endo B

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Kimtrac

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:I

  • JETIP Instruments

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:I

  • Leetrac

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Leetrac

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:I

  • Vibrapost

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • JETIP Instruments

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • BSN2425

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • BL-B Kondenser

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

Rows 1-50 of 217

Showing 1-50 of 217

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000023296
EU VAT number
1198163609
EUDAMED status
Active
EUDAMED registered name
B&L Biotech
Registered address
95, Gwangdeokdong-ro, Danwon-gu, 15462, Ansan-si, South Korea
PRRC contact
Jong-il Choi(public in EUDAMED)

FDA establishments1

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

  • B&L Biotech Co., Ltd. US

Frequently asked questions

How many devices does B&L Biotech have in the registry?

The registry currently lists 217 devices for B&L Biotech. Devices recorded under merged duplicate company entries are counted once.

Which registries list B&L Biotech's devices?

Among its 50 most recently registered devices, B&L Biotech has devices listed in EUDAMED (50 devices) and FDA GUDID (43 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do B&L Biotech's devices fall under?

Among its 50 most recently registered devices, the classes recorded for B&L Biotech's devices are Class I and Class IIa. Each device page shows its own class and authorisation.

What are the newest devices from B&L Biotech in the registry?

The most recently registered devices listed for B&L Biotech include SPRDS, SPRDN, Leetrac and BSN2123.

Which FDA establishments are linked to B&L Biotech?

1 FDA establishment is linked to B&L Biotech in the registry; they are listed on the company page.

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