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Sign in to claim this brandTRONEX INTERNATIONAL, INC.
US
Last updated May 27, 2026
What TRONEX INTERNATIONAL, INC. makes
The company manufactures single-use personal protective and procedural barriers, including nitrile and natural rubber examination gloves, scrub suits, pressure bandages, isolation gowns, professional examination gowns, shoe covers, and surgical hoods. These products are designed for medical, surgical, and clinical environments to reduce contamination risk during patient care and procedures. The portfolio also covers non-latex alternatives to accommodate allergy-sensitive users.
The devices fall under FDA-regulated Class I and Class II categories, with most entries listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States, adhering to applicable U.S. regulatory requirements for medical device compliance.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- tronexcompany.com
- —
- —
- [email protected]
- Phone
- 973-335-2888
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 615425519
Catalogue (447)
Page 4 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tronex International, Inc. | 3649-30 | FDA UDI | Class I | Active |
| Tronex International, Inc. | 8530-35 | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCB1105A | FDA UDI | Class I | Active |
| Tronex International, Inc. | 3010-05 | FDA UDI | Class I | Active |
| Tronex International, Inc. | 5440Y | FDA UDI | Class I | Active |
| Tronex International, Inc. | EBD5766N | FDA UDI | Class I | Active |
| Tronex International, Inc. | 9250-05 | FDA UDI | Class I | Active |
| Tronex International, Inc. | MLN46425Y | FDA UDI | Class I | Active |
| Tronex International, Inc. | 9672-30 | FDA UDI | Class I | Active |
| Tronex International, Inc. | SMS58540B | FDA UDI | Class I | Active |
| Tronex International, Inc. | 577035W | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCB0205C | FDA UDI | Class I | Active |
| Tronex International, Inc. | 9415-35 | FDA UDI | Class I | Active |
| Tronex International, Inc. | 7633B | FDA UDI | Class I | Active |
| Tronex International, Inc. | 4866B | FDA UDI | Class I | Active |
| Tronex International, Inc. | EBV2021N | FDA UDI | Class I | Active |
| Tronex International, Inc. | SMS54930W | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCM95635M | FDA UDI | Class I | Active |
| Tronex International, Inc. | 9393-05 | FDA UDI | Class I | Active |
| Tronex International, Inc. | 5055Y | FDA UDI | Class I | Active |
| Tronex International, Inc. | 9394-20 | FDA UDI | Class I | Active |
| Tronex International, Inc. | EBC2047N | FDA UDI | Class I | Active |
| Tronex International, Inc. | MLN94525Y | FDA UDI | Class II | Active |
| Tronex International, Inc. | SMS54935W | FDA UDI | Class I | Active |
| Tronex International, Inc. | MLN51625Y | FDA UDI | Class I | Active |
| Tronex International, Inc. | 7945-20 | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCB4266N | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCM95630G | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCM90130G | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCM90135G | FDA UDI | Class I | Active |
| Tronex International, Inc. | 9211-35 | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCM95645M | FDA UDI | Class I | Active |
| Tronex International, Inc. | 7945-35 | FDA UDI | Class I | Active |
| Tronex International, Inc. | 541025Y | FDA UDI | Class I | Active |
| Tronex International, Inc. | 9099-35 | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCM50920B | FDA UDI | Class I | Active |
| Tronex International, Inc. | 9177STR-30 | FDA UDI | Class I | Active |
| Tronex International, Inc. | 4888B | FDA UDI | Class I | Active |
| Tronex International, Inc. | EBD2000N | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCM24555M | FDA UDI | Class I | Active |
| Tronex International, Inc. | SMS58520B | FDA UDI | Class I | Active |
| Tronex International, Inc. | EBD2007N | FDA UDI | Class I | Active |
| Tronex International, Inc. | SMS57365W | FDA UDI | Class I | Active |
| Tronex International, Inc. | 3110-05 | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCM50940B | FDA UDI | Class I | Active |
| Tronex International, Inc. | 7610B | FDA UDI | Class I | Active |
| Tronex International, Inc. | 48635B | FDA UDI | Class I | Active |
| Tronex International, Inc. | TCB4222N | FDA UDI | Class I | Active |
| Tronex International, Inc. | SMS55130B | FDA UDI | Class I | Active |
| Tronex International, Inc. | EBC2044N | FDA UDI | Class I | Active |
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