# Bio Protech Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Bio Protech Inc. is a medical device manufacturer based in South Korea, with 165 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class IIb, I and IIa; FDA Class II) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/bio-protech-inc>
- Country: South Korea (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: KR-MF-000012687

## Figures

- Devices: 165
- EU certificates: 1
- 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 149, FDA GUDID 18, FDA 510(k) 17
- Device classes: EU Class IIb 84, EU Class I 46, EU Class IIa 18, FDA Class II 17
- EMDN [K02 Electrosurgery devices, single-use](https://devicerts.com/categories/emdn/K02): 84 devices
- EMDN [C02 Arrhythmology devices](https://devicerts.com/categories/emdn/C02): 45 devices
- EMDN [N01 Encephalic and peripheral nervous system devices](https://devicerts.com/categories/emdn/N01): 19 devices

## Sites and related companies

- Authorised representative: [Meridius Medical Europe Limited](https://devicerts.com/representatives/meridius-medical-europe-limited-ie-ar-000004258) (Ireland)

## Devices

The first 50 of 165, in the order of the canonical page, which lists them all.

- [e-LECTRO PLATE](https://devicerts.com/devices/e-lectro-plate-t9551f) · ref T9551F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9612f) · ref 9612F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9642f) · ref 9642F · Class IIb · EUDAMED · status: Active
- [e-LECTRO PLATE](https://devicerts.com/devices/e-lectro-plate-t9552c) · ref T9552C · Class IIb · EUDAMED · status: Active
- [e-LECTRO PLATE](https://devicerts.com/devices/e-lectro-plate-t9552f) · ref T9552F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9611c) · ref 9611C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9611f) · ref 9611F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9612c) · ref 9612C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9631c) · ref 9631C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9522c) · ref 9522C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9632f) · ref P9632F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9511f) · ref P9511F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9531c) · ref P9531C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9521f) · ref P9521F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9641f) · ref P9641F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9632f) · ref 9632F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9571f) · ref 9571F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9511c) · ref P9511C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9642c) · ref 9642C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9512f) · ref P9512F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9552f) · ref P9552F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9522f) · ref P9522F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9561f) · ref 9561F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9551c) · ref 9551C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9512c) · ref 9512C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9572f) · ref 9572F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9632c) · ref 9632C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9521c) · ref P9521C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9571f) · ref P9571F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9611c) · ref P9611C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9571c) · ref P9571C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9521f) · ref 9521F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9522f) · ref 9522F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9541f) · ref P9541F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9512c) · ref P9512C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9512f) · ref 9512F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9642f) · ref P9642F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9612f) · ref P9612F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9531f) · ref P9531F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9541c) · ref P9541C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9572f) · ref P9572F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9521c) · ref 9521C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9532f) · ref P9532F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9552c) · ref 9552C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9631f) · ref 9631F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9642c) · ref P9642C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9532c) · ref P9532C · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9611f) · ref P9611F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-p9542f) · ref P9542F · Class IIb · EUDAMED · status: Active
- [Proplate](https://devicerts.com/devices/proplate-9641c) · ref 9641C · Class IIb · EUDAMED · status: Active

## EU certificates

- C611944 · Quality management system · MDR · notified body DNV Product Assurance AS · issued 2025-10-15 · expires 2030-10-15 · status: issued

## Source and citation

- Cite as: Bio Protech Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/bio-protech-inc (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [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/bio-protech-inc.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/bio-protech-inc
- 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.