# B&L Biotech

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/bl-biotech>
- Also registered as: B&L BIOTECH CO., INC
- Country: South Korea (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: KR-MF-000023296

## Figures

- Devices: 217
- FDA recalls (matched to the firm by name): 0
- FDA establishments: 1

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: EUDAMED 217, FDA GUDID 202
- Device classes: EU Class I 157, EU Class IIa 60
- EMDN [Q01 Dental devices](https://devicerts.com/categories/emdn/Q01): 137 devices
- EMDN [L15 Odontostomatology instruments, reusable](https://devicerts.com/categories/emdn/L15): 46 devices
- EMDN [V03 Measurement devices](https://devicerts.com/categories/emdn/V03): 29 devices
- EMDN [L16 Diagnostic instruments, reusable](https://devicerts.com/categories/emdn/L16): 5 devices

## Sites and related companies

- Authorised representative: [Emergo Europe B.V.](https://devicerts.com/representatives/emergo-europe-bv-nl-ar-000000116) (Netherlands)

## Devices

The first 50 of 217, in the order of the canonical page, which lists them all.

- [Sprds](https://devicerts.com/devices/sprds-sprds) · Class IIa · EUDAMED · status: Active
- [Sprdn](https://devicerts.com/devices/sprdn-sprdn) · Class IIa · EUDAMED · status: Active
- [Leetrac](https://devicerts.com/devices/leetrac-leetrac-ed74713c) · Class I · EUDAMED · status: Active
- [Leetrac](https://devicerts.com/devices/leetrac-leetrac) · Class I · EUDAMED · status: Active
- [BSN2123](https://devicerts.com/devices/bsn2123-bp-b1-96885b8d) · Class IIa · EUDAMED, GUDID · status: Active
- [BMN2425](https://devicerts.com/devices/bmn2425-bp-b1-398dce39) · Class IIa · EUDAMED, GUDID · status: Active
- [BSN2225](https://devicerts.com/devices/bsn2225-bp-b1-14792a5f) · Class IIa · EUDAMED, GUDID · status: Active
- [Is Tip](https://devicerts.com/devices/is-tip-19110477) · Class IIa · EUDAMED, GUDID · status: Active
- [Pomo](https://devicerts.com/devices/pomo-19110651) · Class I · EUDAMED, GUDID · status: Active
- [Endo B](https://devicerts.com/devices/endo-b-19140696) · Class I · EUDAMED · status: Active
- [BP6012](https://devicerts.com/devices/bp6012-cl-a1) · Class IIa · EUDAMED, GUDID · status: Active
- [Jetip](https://devicerts.com/devices/jetip-19110392) · Class IIa · EUDAMED, GUDID · status: Active
- [BSN2225](https://devicerts.com/devices/bsn2225-bp-b1) · Class IIa · EUDAMED, GUDID · status: Active
- [BSN2425](https://devicerts.com/devices/bsn2425-bp-b1-93823aab) · Class IIa · EUDAMED, GUDID · status: Active
- [JETIP Instruments Micro Mirror](https://devicerts.com/devices/jetip-instruments-micro-mirror-19115465) · Class I · EUDAMED, GUDID · status: Active
- [BMN2425](https://devicerts.com/devices/bmn2425-bp-b1) · Class IIa · EUDAMED, GUDID · status: Active
- [Kimtrac](https://devicerts.com/devices/kimtrac-19111153) · Class I · EUDAMED, GUDID · status: Active
- [Endo B](https://devicerts.com/devices/endo-b-19140771) · Class I · EUDAMED · status: Active
- [BP4004](https://devicerts.com/devices/bp4004-cl-a1) · Class IIa · EUDAMED, GUDID · status: Active
- [JETIP Instruments](https://devicerts.com/devices/jetip-instruments-jibh) · Class I · EUDAMED, GUDID · status: Active
- [Is Tip](https://devicerts.com/devices/is-tip-19110446) · Class IIa · EUDAMED, GUDID · status: Active
- [Beta Mini](https://devicerts.com/devices/beta-mini-bp-b1-bb3d1e6f) · Class IIa · EUDAMED, GUDID · status: Active
- [Bl Tip](https://devicerts.com/devices/bl-tip-19110279) · Class IIa · EUDAMED, GUDID · status: Active
- [BMN2423](https://devicerts.com/devices/bmn2423-bp-b1-bf74a6ec) · Class IIa · EUDAMED, GUDID · status: Active
- [BL-S Kondenser](https://devicerts.com/devices/bl-s-kondenser-19110064) · Class I · EUDAMED, GUDID · status: Active
- [BSN2420](https://devicerts.com/devices/bsn2420-bp-b1-35138d26) · Class IIa · EUDAMED, GUDID · status: Active
- [JETIP Instruments](https://devicerts.com/devices/jetip-instruments-19115151) · Class I · EUDAMED, GUDID · status: Active
- [JETIP Instruments](https://devicerts.com/devices/jetip-instruments-jb2) · Class I · EUDAMED, GUDID · status: Active
- [BMN2420](https://devicerts.com/devices/bmn2420-bp-b1) · Class IIa · EUDAMED, GUDID · status: Active
- [Kimtrac](https://devicerts.com/devices/kimtrac-ktnnh) · Class I · EUDAMED, GUDID · status: Active
- [BSN2820](https://devicerts.com/devices/bsn2028-bp-b1) · Class IIa · EUDAMED, GUDID · status: Active
- [Jetip](https://devicerts.com/devices/jetip-19110385) · Class IIa · EUDAMED, GUDID · status: Active
- [Endo R](https://devicerts.com/devices/endo-r-19140122) · Class I · EUDAMED, GUDID · status: Active
- [BL-S Kondenser](https://devicerts.com/devices/bl-s-kondenser-19110088) · Class I · EUDAMED, GUDID · status: Active
- [Como](https://devicerts.com/devices/como-19111337) · Class I · EUDAMED, GUDID · status: Active
- [Endo M&R](https://devicerts.com/devices/endo-mandr-enmssgrlg-r) · Class I · EUDAMED, GUDID · status: Active
- [B&L GP Gauge&Cutter](https://devicerts.com/devices/bandl-gp-gaugeandcutter-ggac) · ref GGAC · Class I · EUDAMED, GUDID · status: Active
- [Kimtrac](https://devicerts.com/devices/kimtrac-19111184) · Class I · EUDAMED, GUDID · status: Active
- [BL-B Kondenser](https://devicerts.com/devices/bl-b-kondenser-19110118) · Class I · EUDAMED, GUDID · status: Active
- [BP5506](https://devicerts.com/devices/bp5506-cl-a1) · Class IIa · EUDAMED, GUDID · status: Active
- [JETIP Instruments](https://devicerts.com/devices/jetip-instruments-19115045) · Class I · EUDAMED, GUDID · status: Active
- [Endo B](https://devicerts.com/devices/endo-b-19140795) · Class I · EUDAMED · status: Active
- [Kimtrac](https://devicerts.com/devices/kimtrac-ktrp2n) · Class I · EUDAMED, GUDID · status: Active
- [JETIP Instruments](https://devicerts.com/devices/jetip-instruments-jpp) · Class I · EUDAMED, GUDID · status: Active
- [Leetrac](https://devicerts.com/devices/leetrac-19110958) · Class I · EUDAMED, GUDID · status: Active
- [Leetrac](https://devicerts.com/devices/leetrac-ltsbs) · Class I · EUDAMED, GUDID · status: Active
- [Vibrapost](https://devicerts.com/devices/vibrapost-19110286) · Class IIa · EUDAMED, GUDID · status: Active
- [JETIP Instruments](https://devicerts.com/devices/jetip-instruments-19115038) · Class I · EUDAMED, GUDID · status: Active
- [BSN2425](https://devicerts.com/devices/bsn2425-bp-b1) · Class IIa · EUDAMED, GUDID · status: Active
- [BL-B Kondenser](https://devicerts.com/devices/bl-b-kondenser-19110125) · Class I · EUDAMED, GUDID · status: Active

## Source and citation

- Cite as: B&L Biotech. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/bl-biotech (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/bl-biotech.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/bl-biotech
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.
