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US
Last updated September 17, 2026
What TRUER MEDICAL, INC. makes
The company manufactures single-use and reusable medical devices for respiratory and airway management, including electronic oesophageal stethoscopes, gas-sampling respiratory tubing, endotracheal tube introducers, and artificial airway stylets. It also produces reusable medical accessories such as electrical connection cables, reusable mouthguards, oesophageal bougies, and reusable surgical tools like the Adroit Surgical line. Infrared skin thermometers are part of its portfolio, along with nasal cannulas and other airway support devices.
The portfolio includes devices classified as Class I, Class II, and unclassified (U) under regulatory frameworks, with submissions documented in FDA 510(k) and UDI registries. These products are intended for use in clinical and surgical settings, adhering to US regulatory standards. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Truer Medical, Inc. manufacture?
Truer Medical, Inc. specializes in a range of medical devices primarily focused on respiratory and airway management. Their portfolio includes single-use items like electronic oesophageal stethoscopes, gas-sampling respiratory tubing, endotracheal tube introducers, and artificial airway stylets. They also produce reusable devices such as electrical connection cables, mouthguards, oesophageal bougies, reusable surgical tools (e.g., the Adroit Surgical line), and infrared skin thermometers. Nasal cannulas and other airway support devices are also part of their offerings.
Where is Truer Medical, Inc. based, and how does that affect its regulatory standing?
Truer Medical, Inc. is based in the United States, which means its devices are subject to FDA regulatory oversight. The company’s products are designed to comply with US regulatory standards, including submissions documented in FDA 510(k) premarket notifications and UDI (Unique Device Identification) registries. Being US-based ensures alignment with FDA requirements for device classification, labeling, and post-market surveillance.
Which regulatory registries list Truer Medical, Inc.’s devices, and why?
Truer Medical, Inc.’s devices are listed in the FDA 510(k) and UDI registries. The 510(k) submissions are used to demonstrate that new devices are substantially equivalent to legally marketed predicates, while UDI registration ensures each device has a unique identifier for tracking and traceability. These registries help ensure compliance with US regulatory requirements and facilitate transparency in the medical device supply chain.
How are Truer Medical, Inc.’s devices classified under US regulations?
Truer Medical, Inc.’s devices fall into different regulatory classes based on their risk levels: Class I (low risk, generally exempt from premarket notification), Class II (moderate risk, requiring special controls), and unclassified (U) devices, which may require case-by-case evaluation. Classification determines the regulatory pathway, such as 510(k) submissions or other premarket requirements, ensuring appropriate oversight for patient safety and device performance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1050 N Batavia St Ste C, ORANGE, CA, 92867
- Website
- truermedical.com
- —
- —
- [email protected]
- Phone
- 7146289785
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3003240904
- DUNS Number
- 003530786
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Gas Sampling Line 120' X .050' X .112' M/M | 90158 | FDA UDI | Class I | Active |
| Nasal Cannula | 90413 | FDA UDI | Class I | Active |
| QuickSplint Kit Pouch | 90525 | FDA UDI | Class I | Active |
| Adroit surgical | 90545 | FDA UDI | Class I | Active |
| Truer Medical, Inc. | ES 18400 | FDA UDI | Class II | Active |
| 400 Series Type Monitor Cable, Right Angle | 70321 | FDA UDI | Class II | Active |
| GAS SAMPLING LINE 120'x.050'x.108' M/F | 90151 | FDA UDI | Class I | Active |
| Gas Sampling Line 120'x.040'x.112' M/M | 90148 | FDA UDI | Class I | Active |
| Truer Medical, Inc. | ES 24400 | FDA UDI | Class II | Active |
| Truer Medical, Inc. | GP 9400 | FDA UDI | Class II | Active |
| Adroit Surgical | 90546 | FDA UDI | Class I | Active |
| Sharn by Marketlab | Sharn SSP-400 | FDA UDI | Class II | Active |
| Orofacial Therapeutics | 90509 | FDA UDI | U | Active |
| Truer Medical, Inc. | ES 1800 | FDA UDI | Class II | Active |
| Truer Medical, Inc. | ES 12400H | FDA UDI | Class II | Active |
| Truer Medical, Inc. | ES 18400H | FDA UDI | Class II | Active |
| Adult Headstrap | 90517 | FDA UDI | Class I | Active |
| Gas Sampling Line 120 x .048 x .108 M/M CO-EX | 90100 | FDA UDI | Class I | Active |
| Pediatric Stylet | 90201 | FDA UDI | Class I | Active |
| Co Ex Line 96'x.048'x112' M/M | 90116 | FDA UDI | Class I | Active |
| Gas Sampling Line 120'x.060'x.112' M/M | 90169 | FDA UDI | Class I | Active |
| Truer Bougie | 90552 | FDA UDI | Class I | Active |
| Pediatric Headstrap | 90518 | FDA UDI | Class I | Active |
| 400 Series Right Angle Cable (160 cm) | 70326 | FDA UDI | Class II | Active |
| Truer Medical, Inc. | ES 24400H | FDA UDI | Class II | Active |
| Truer Medical, Inc. | ES 2400 | FDA UDI | Class II | Active |
| Truer Medical, Inc. | ES 9400 | FDA UDI | Class II | Active |
| Gas Sampling Line 120'X.050'x.108' M/M | 90150 | FDA UDI | Class I | Active |
| Truer Medical, Inc. | TP 400 | FDA UDI | Class II | Active |
| 400 Series Right Angle Cable (80 cm) | 70323 | FDA UDI | Class II | Active |
| Truer Medical, Inc. | ES 12400 | FDA UDI | Class II | Active |
| Truer Medical, Inc. | ES 9000 | FDA UDI | Class II | Active |
| GAS SAMPLING LINE 96'x.050'x.112' MM | 90156 | FDA UDI | Class I | Active |
| Adult Stylet | 90200 | FDA UDI | Class I | Active |
| Truer Medical, Inc. | GP 14400 | FDA UDI | Class II | Active |
| HP to 3.5mm Phonojack Cable with Shrinkwrap | 70309 | FDA UDI | Class II | Active |
| Truer Medical, Inc. | ES 1200 | FDA UDI | Class II | Active |
| HP 400 series type monitor cable | 70320 | FDA UDI | Class II | Active |
| Truer Medical, Inc. | SSP 400 | FDA UDI | Class II | Active |
| Truer Bougie Coiled | 90553 | FDA UDI | Class I | Active |
| Gas Sampling Line 120'x.048'x.108' M/F | 90101 | FDA UDI | Class I | Active |
| Skin Sensor Probe, General Purpose Probe, Tympanic Probe | K101244 | FDA 510(k) | Class II | Active |
| Esophageal Stethoscope | K092716 | FDA 510(k) | Class II | Active |
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