# Bionix, LLC

> Medical device manufacturer record on deviCERTS, compiled from public registries. Bionix, LLC is a medical device manufacturer based in the United States, with 220 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II; EU Class I) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/bionix-llc>
- Also registered as: Bionix Corp.
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: US-MF-000020408
- FDA FEI: 1526854
- DUNS: 117844489

## Figures

- Devices: 220
- FDA recalls (matched to the firm by name): 0

## Registry facts

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

- Registries: FDA GUDID 218, EUDAMED 67, FDA 510(k) 2
- Device classes: FDA Class I 96, FDA Class II 65, EU Class I 59
- EMDN [Q03 ENT devices](https://devicerts.com/categories/emdn/Q03): 39 devices
- EMDN [Z12 Instruments for functional explorations and therapeutic interventions](https://devicerts.com/categories/emdn/Z12): 11 devices
- EMDN [V90 Various devices not included in other classes](https://devicerts.com/categories/emdn/V90): 8 devices
- EMDN [A06 Drainage and fluids collection devices](https://devicerts.com/categories/emdn/A06): 1 devices

## Sites and related companies

- Authorised representative: [Obelis S.A.](https://devicerts.com/representatives/obelis-sa-be-ar-000000106) (Belgium)

## Devices

The first 50 of 220, in the order of the canonical page, which lists them all.

- [Microsuction Replacement Pack 2651](https://devicerts.com/devices/microsuction-replacement-pack-2651-ls-02651) · Class I · GUDID · status: Listed
- [Lighted Magnetic Foreign Body Removal Tool 3525](https://devicerts.com/devices/lighted-magnetic-foreign-body-removal-tool-3525) · Class I · GUDID · status: Listed
- [Rechargeable Light Source 3600](https://devicerts.com/devices/rechargeable-light-source-3600-dcf821d5) · Class I · GUDID · status: Listed
- [ClearLook Variety Pack with Rechargeable Light Source 3645](https://devicerts.com/devices/clearlook-variety-pack-with-rechargeable-light-source-3645) · Class I · GUDID · status: Listed
- [ClearLook CeraSpoon 3350](https://devicerts.com/devices/clearlook-ceraspoon-3350) · Class I · EUDAMED, GUDID · status: Active
- [ClearLook LEC, Sample Pack-Curettes Only 23300](https://devicerts.com/devices/clearlook-lec-sample-pack-curettes-only-23300) · Class I · GUDID · status: Listed
- [ClearLook Variety, 50ct Refill Pack 3445](https://devicerts.com/devices/clearlook-variety-50ct-refill-pack-3445) · Class I · EUDAMED, GUDID · status: Active
- [Lighted Magnetic Foreign Body Removal Tool 3521](https://devicerts.com/devices/lighted-magnetic-foreign-body-removal-tool-3521) · Class I · GUDID · status: Listed
- [ClearLook CeraSpoon, 50ct Refill Pack 3450](https://devicerts.com/devices/clearlook-ceraspoon-50ct-refill-pack-3450) · Class I · EUDAMED, GUDID · status: Active
- [Lighted Ear Curette](https://devicerts.com/devices/lighted-ear-curette-2512) · ref 2512 · Class I · EUDAMED, GUDID · status: Active
- [Lighted Ear Curette](https://devicerts.com/devices/lighted-ear-curette-3345-e096db1b) · ref 3345 · Class I · EUDAMED, GUDID · status: Active
- [Pelvis Belly Large Abdominal Insert PPRT-5106](https://devicerts.com/devices/pelvis-belly-large-abdominal-insert-pprt-5106) · Class II · GUDID · status: Active
- [Lighted Placement Tool 2850](https://devicerts.com/devices/lighted-placement-tool-2850) · Class I · GUDID · status: Listed
- [Prone Breast System PBRT-6025-03](https://devicerts.com/devices/prone-breast-system-pbrt-6025-03) · Class II · GUDID · status: Active
- [SecureVac™ Immobilization System SVRT-7915](https://devicerts.com/devices/securevac-immobilization-system-svrt-7915) · Class II · GUDID · status: Active
- [Preemie Transport Blanket 21125](https://devicerts.com/devices/preemie-transport-blanket-21125) · Class I · GUDID · status: Withdrawn
- [SafeStraw™ Drinking Aid for Thin Liquid 202](https://devicerts.com/devices/safestraw-drinking-aid-for-thin-liquid-202) · Class I · GUDID · status: Withdrawn
- [Prone Breast, Hardware Kit, Head Rest Push Button Assembly Replacement PBRT-6302](https://devicerts.com/devices/prone-breast-hardware-kit-head-rest-push-button-assembly-rep-pbrt-6302) · Class II · GUDID · status: Active
- [Sample, Lighted FlexLoop 22205](https://devicerts.com/devices/sample-lighted-flexloop-22205) · Class I · GUDID · status: Withdrawn
- [SecureVac™ Immobilization System SVRT-7600](https://devicerts.com/devices/securevac-immobilization-system-svrt-7600) · Class II · GUDID · status: Active
- [SecureVac™ Immobilization System SVRT-7820-A](https://devicerts.com/devices/securevac-immobilization-system-svrt-7820-a) · Class II · GUDID · status: Active
- [SecureVac™ Immobilization System SVRT-7625](https://devicerts.com/devices/securevac-immobilization-system-svrt-7625) · Class II · GUDID · status: Active
- [Opti-Tatt™ Field Borders UTRT-4300](https://devicerts.com/devices/opti-tatt-field-borders-utrt-4300) · Class I · GUDID · status: Listed
- [SecureFoam 25038](https://devicerts.com/devices/securefoam-25038) · Class II · GUDID · status: Active
- [IsoMark™ UTRT-3101](https://devicerts.com/devices/isomark-3101-5d5fbbe6) · Class I · GUDID · status: Withdrawn
- [SecureFoam 5038](https://devicerts.com/devices/securefoam-5038-50c16cad) · Class II · GUDID · status: Active
- [OtoClear SprayWash Adapter Wand 27219](https://devicerts.com/devices/otoclear-spraywash-adapter-wand-27219) · Class I · GUDID · status: Listed
- [Ear Wax Removal Kit 702](https://devicerts.com/devices/ear-wax-removal-kit-702) · Class I · GUDID · status: Listed
- [SecureFoam 5036](https://devicerts.com/devices/securefoam-5036-3f342c2b) · Class II · GUDID · status: Active
- [Lighted Articulating - Sample 22511](https://devicerts.com/devices/lighted-articulating-sample-22511) · Class I · GUDID · status: Listed
- [Bionix, LLC UTRT-3105](https://devicerts.com/devices/bionix-llc-3105) · Class I · GUDID · status: Listed
- [Sample, Lighted Suction Handle 22625](https://devicerts.com/devices/sample-lighted-suction-handle-22625) · Class I · GUDID · status: Listed
- [Bionix, LLC UTRT-3100](https://devicerts.com/devices/bionix-llc-3100) · Class I · GUDID · status: Listed
- [Lighted Ear Curette Demo Pack (monthly mailer) 22201](https://devicerts.com/devices/lighted-ear-curette-demo-pack-monthly-mailer-22201) · Class I · GUDID · status: Listed
- [Igloo Wound Irrigator 25000](https://devicerts.com/devices/igloo-wound-irrigator-25000) · Class I · GUDID · status: Listed
- [Lighted Microsuction System 2650](https://devicerts.com/devices/microsuction-stater-pack-ls-02650) · Class II · GUDID · status: Listed
- [Bionix Development Corporation Sp-20913](https://devicerts.com/devices/bionix-development-corporation-20913) · Class II · GUDID · status: Active
- [SecureVac™ Immobilization System SVRT-7133](https://devicerts.com/devices/securevac-immobilization-system-svrt-7133) · Class II · GUDID · status: Active
- [Swaddler for Phototherapy 1100](https://devicerts.com/devices/swaddler-for-phototherapy-1100) · Class II · GUDID · status: Active
- [27247 Sp-27247](https://devicerts.com/devices/sample-otoclear-r-ear-irrigation-system-220v-27247) · Class I · GUDID · status: Withdrawn
- [Sample, Lighted Forceps for Foreign Body Removal SP-22750](https://devicerts.com/devices/sample-lighted-forceps-for-foreign-body-removal-22750) · Class I · GUDID · status: Listed
- [SafeStraw 1510](https://devicerts.com/devices/safestraw-1510) · Class I · GUDID · status: Listed
- [SecureFoam 5037](https://devicerts.com/devices/securefoam-5037-3de0a86c) · Class II · GUDID · status: Active
- [AfterSwim 530](https://devicerts.com/devices/afterswim-530) · Class I · GUDID · status: Withdrawn
- [OtoClear Tip Sample 27230](https://devicerts.com/devices/otoclear-tip-sample-27230) · Class I · GUDID · status: Listed
- [Pelvis Belly Replacement Face Cushion Assembly PPRT-5107](https://devicerts.com/devices/pelvis-belly-replacement-face-cushion-assembly-pprt-5107) · Class II · GUDID · status: Active
- [IsoMark™ UTRT-3102](https://devicerts.com/devices/isomark-3102) · Class I · GUDID · status: Listed
- [Pelvis Belly Replacement Arm Rest Cushion PPRT-5103](https://devicerts.com/devices/pelvis-belly-replacement-arm-rest-cushion-pprt-5103) · Class II · GUDID · status: Active
- [Bionix Development Corporation Sp-20921](https://devicerts.com/devices/bionix-development-corporation-20921) · Class II · GUDID · status: Active
- [OtoClear SprayWash System, Single Use Sample 27291](https://devicerts.com/devices/otoclear-spraywash-system-single-use-sample-27291) · Class I · GUDID · status: Withdrawn

## Source and citation

- Cite as: Bionix, LLC. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/bionix-llc (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/bionix-llc.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/bionix-llc
- 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.