{ "format": "devicerts.manufacturer.v1", "cite_as": "Bio Protech Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/bio-protech-inc (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/manufacturers/bio-protech-inc", "json_url": "https://devicerts.com/manufacturers/bio-protech-inc.json", "markdown_url": "https://devicerts.com/manufacturers/bio-protech-inc.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" }, { "registry": "FDA GUDID", "url": "https://accessgudid.nlm.nih.gov/" }, { "registry": "FDA 510(k)", "url": "https://open.fda.gov/apis/device/510k/" }, { "registry": "FDA registration and listing", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm" } ], "eudamed_record_synced": "2026-11-07", "fda_recalls_as_of": "2026-11-01", "registry_facts_computed": "2026-11-15", "status_as_of": "2026-11-15", "license": "CC BY 4.0", "license_url": "https://creativecommons.org/licenses/by/4.0/", "license_scope": "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", "disclaimer": "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." }, "manufacturer": { "name": "Bio Protech Inc.", "url": "https://devicerts.com/manufacturers/bio-protech-inc", "registered_as": null, "abbreviated_name": null, "also_registered_as": [], "country": "South Korea", "country_basis": "from SRN", "eudamed_status": { "status": "active", "since_year": null }, "verified": false, "roles": [ "Manufacturer" ], "registrations": [ "EUDAMED", "FDA" ], "identifiers": [ { "label": "EUDAMED SRN", "value": "KR-MF-000012687" } ], "summary": "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.", "noindex": false }, "counts": { "devices": 165, "devices_note": null, "certificates": 1, "fda_recalls_matched_by_name": 0, "fda_recalls_ongoing": 0, "fda_recalls_ongoing_recent": 0, "fda_recalls_ongoing_before": null, "fda_establishments": 1, "sites": 0 }, "registry_facts": { "covers": "Every device of the manufacturer. A device listed in two registries counts in both.", "registries": [ { "registry": "EUDAMED", "devices": 149 }, { "registry": "FDA GUDID", "devices": 18 }, { "registry": "FDA 510(k)", "devices": 17 } ], "device_classes": [ { "class": "EU Class IIb", "devices": 84 }, { "class": "EU Class I", "devices": 46 }, { "class": "EU Class IIa", "devices": 18 }, { "class": "FDA Class II", "devices": 17 } ], "top_emdn_categories": [ { "code": "K02", "name": "Electrosurgery devices, single-use", "url": "https://devicerts.com/categories/emdn/K02", "devices": 84 }, { "code": "C02", "name": "Arrhythmology devices", "url": "https://devicerts.com/categories/emdn/C02", "devices": 45 }, { "code": "N01", "name": "Encephalic and peripheral nervous system devices", "url": "https://devicerts.com/categories/emdn/N01", "devices": 19 } ] }, "related": { "site_of": null, "part_of": null, "sites": [], "authorised_representatives": [ { "name": "Meridius Medical Europe Limited", "url": "https://devicerts.com/representatives/meridius-medical-europe-limited-ie-ar-000004258", "country": "Ireland" } ] }, "devices": { "shown": 50, "total": 165, "all_devices_url": "https://devicerts.com/manufacturers/bio-protech-inc", "items": [ { "name": "e-LECTRO PLATE", "url": "https://devicerts.com/devices/e-lectro-plate-t9551f", "model_reference": "T9551F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9612f", "model_reference": "9612F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9642f", "model_reference": "9642F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "e-LECTRO PLATE", "url": "https://devicerts.com/devices/e-lectro-plate-t9552c", "model_reference": "T9552C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "e-LECTRO PLATE", "url": "https://devicerts.com/devices/e-lectro-plate-t9552f", "model_reference": "T9552F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9611c", "model_reference": "9611C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9611f", "model_reference": "9611F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9612c", "model_reference": "9612C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9631c", "model_reference": "9631C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9522c", "model_reference": "9522C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9632f", "model_reference": "P9632F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9511f", "model_reference": "P9511F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9531c", "model_reference": "P9531C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9521f", "model_reference": "P9521F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9641f", "model_reference": "P9641F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9632f", "model_reference": "9632F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9571f", "model_reference": "9571F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9511c", "model_reference": "P9511C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9642c", "model_reference": "9642C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9512f", "model_reference": "P9512F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9552f", "model_reference": "P9552F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9522f", "model_reference": "P9522F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9561f", "model_reference": "9561F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9551c", "model_reference": "9551C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9512c", "model_reference": "9512C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9572f", "model_reference": "9572F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9632c", "model_reference": "9632C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9521c", "model_reference": "P9521C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9571f", "model_reference": "P9571F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9611c", "model_reference": "P9611C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9571c", "model_reference": "P9571C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9521f", "model_reference": "9521F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9522f", "model_reference": "9522F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9541f", "model_reference": "P9541F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9512c", "model_reference": "P9512C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9512f", "model_reference": "9512F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9642f", "model_reference": "P9642F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9612f", "model_reference": "P9612F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9531f", "model_reference": "P9531F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9541c", "model_reference": "P9541C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9572f", "model_reference": "P9572F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9521c", "model_reference": "9521C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9532f", "model_reference": "P9532F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9552c", "model_reference": "9552C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9631f", "model_reference": "9631F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9642c", "model_reference": "P9642C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9532c", "model_reference": "P9532C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9611f", "model_reference": "P9611F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-p9542f", "model_reference": "P9542F", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false }, { "name": "Proplate", "url": "https://devicerts.com/devices/proplate-9641c", "model_reference": "9641C", "device_class": "Class IIb", "registries": [ "EUDAMED" ], "status": "Active", "decision_date": null, "open_recall": false } ] }, "certificates": [ { "number": "C611944", "type": "Quality management system", "legislation": "MDR", "notified_body": "DNV Product Assurance AS", "issued": "2025-10-15", "expires": "2030-10-15", "status": "issued", "no_longer_listed": false } ], "recalls": [] }