{ "format": "devicerts.device.v1", "cite_as": "Vonafill, BNC KOREA, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/vonafill-sub-q (data as of 2026-11-15).", "source": { "canonical_url": "https://devicerts.com/devices/vonafill-sub-q", "json_url": "https://devicerts.com/devices/vonafill-sub-q.json", "markdown_url": "https://devicerts.com/devices/vonafill-sub-q.md", "publisher": "deviCERTS (devicerts.com)", "data_sources": [ { "registry": "EUDAMED", "url": "https://ec.europa.eu/tools/eudamed" } ], "registry_records_last_synced": "2026-11-07", "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/devices/vonafill-sub-q", "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." }, "device": { "name": "Vonafill", "registry_name": "VONAFILL", "url": "https://devicerts.com/devices/vonafill-sub-q", "manufacturer": { "name": "BNC KOREA, Inc.", "url": "https://devicerts.com/manufacturers/bnc-korea-inc", "country": "South Korea", "country_basis": null, "fda_registration_country": null }, "status": { "state": "active", "label": "Active", "detail": "European Union" }, "classification": [ { "class": "Class III", "system": "EU MDR" } ], "identifiers": [ { "label": "Primary DI / UDI-DI", "values": [ { "value": "08809369096158", "registries": [ "EUDAMED" ] } ] }, { "label": "Basic UDI-DI", "values": [ { "value": "880936909BNC001H8", "registries": [ "EUDAMED" ] } ] } ], "product_codes": [], "emdn": [ { "code": "X0303", "term": "SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE" } ], "gmdn": [], "description": null, "noindex": true }, "authorizations": [ { "registry": "EUDAMED", "region": "European Union", "type": "CE/MDR", "number": "880936909BNC001H8", "number_label": "Basic UDI-DI", "device_udi_di": "08809369096158", "date": "2026-10-14", "date_kind": "registered", "decision_code": null, "expires": null, "withdrawn": null, "status": "Active", "status_note": null, "derived_from_gudid": false } ], "no_longer_listed_by": [], "certificates": [ { "number": "2026-AXVI/QS-006", "type": "Quality management system", "legislation": "MDR", "notified_body": "3EC International a.s.", "issued": "2026-10-06", "expires": "2028-01-09", "status": "issued", "no_longer_listed": false }, { "number": "2026-AXVI/TD-006", "type": "Technical documentation", "legislation": "MDR", "notified_body": "3EC International a.s.", "issued": "2026-10-06", "expires": "2028-01-09", "status": "issued", "no_longer_listed": false } ], "recalls": [], "eu_market_availability": null, "properties": [ { "group": "Identity", "fields": [ { "label": "Device name", "values": [ { "value": "Cross-linked Hyaluronic Acid Dermal Filler with Lidocaine", "registries": [ "EUDAMED" ] } ] }, { "label": "Model / reference", "values": [ { "value": "Light", "registries": [ "EUDAMED" ] }, { "value": "CL-S", "registries": [ "EUDAMED" ] }, { "value": "CL-Aqua-s", "registries": [ "EUDAMED" 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