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Sign in to claim this brandDiamatrix
US
Last updated May 27, 2026
What Diamatrix makes
Diamatrix manufactures reusable ophthalmic surgical instruments, including ocular hooks, spatulas, and manipulators for tissue handling, as well as reusable ophthalmic forceps for soft-tissue manipulation. Their portfolio also includes reusable and single-use ophthalmic knives, reusable intraocular scissors, reusable eyelid specula, and reusable corneal markers. Non-illuminating reusable irrigation, infusion, and aspiration cannulas for ophthalmic procedures are also part of their product line.
The company’s devices are classified under FDA’s Class I and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in surgical and diagnostic ophthalmic procedures and adhere to applicable regulatory standards for medical devices 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 Diamatrix manufacture?
Diamatrix specializes in reusable ophthalmic surgical instruments. Their product line includes ocular hooks, spatulas, and manipulators for handling tissue during eye surgeries, as well as reusable forceps designed for soft-tissue manipulation. They also produce reusable ophthalmic knives, intraocular scissors, eyelid specula, and corneal markers. Additionally, Diamatrix offers reusable, non-illuminating irrigation, infusion, and aspiration cannulas for ophthalmic procedures. These devices are primarily used in surgical and diagnostic eye care settings.
Where is Diamatrix based, and what does that mean for their regulatory compliance?
Diamatrix is based in the United States, which means their devices must comply with FDA regulations. The company’s products fall under FDA’s Class I and Unclassified (U) categories, indicating they are generally considered low-risk but still subject to regulatory oversight. Being listed in the FDA’s Unique Device Identifier (UDI) database reflects their compliance with U.S. requirements for device identification and traceability.
Which regulatory registries or databases list Diamatrix’s devices?
Diamatrix’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device has a standardized identifier for tracking, reporting, and regulatory purposes. The UDI system helps streamline compliance and transparency for healthcare providers and regulators.
How are Diamatrix’s devices classified under FDA regulations?
Diamatrix’s devices are classified under two FDA categories: Class I and Unclassified (U). Class I devices are typically the lowest risk and often subject to general controls, while Unclassified (U) devices are evaluated individually based on their specific risks. The classification determines the regulatory pathway and oversight required for each product, ensuring they meet safety and performance standards for use in ophthalmic procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- diamatrix.com
- —
- —
- [email protected]
- Phone
- 281-367-8081
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 809555139
Catalogue (558)
Page 2 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ProTekt | PG 44360MU | FDA UDI | Class I | Active |
| Diamatrix | H376-S | FDA UDI | Class I | Active |
| Diamatrix | C368-20 | FDA UDI | Class I | Active |
| Diamatrix Ltd. | N04886T | FDA UDI | Class I | Active |
| Diamatrix Ltd. | H554-L-D | FDA UDI | Class I | Active |
| ExactEtch | 2115NS | FDA UDI | Class I | Active |
| Diamatrix Ltd. | H854 | FDA UDI | Class I | Active |
| Diamatrix | W34-14 | FDA UDI | Class I | Active |
| Diamatrix | F600T | FDA UDI | Class I | Active |
| Xpand | 346722 | FDA UDI | Class I | Active |
| Diamatrix | F628S | FDA UDI | Class I | Active |
| Diamatrix | L07421 | FDA UDI | Class I | Active |
| ExactEtch | 2110K | FDA UDI | Class I | Active |
| Diamatrix Ltd. | F942S | FDA UDI | Class I | Active |
| Diamatrix Ltd | S515-S | FDA UDI | Class I | Active |
| Diamatrix | F550S | FDA UDI | Class I | Active |
| Diamatrix | B1-21-03 | FDA UDI | Class I | Active |
| Diamatrix | H392-.5-S | FDA UDI | Class I | Active |
| Diamatrix Ltd. | TS16Rx9-15 | FDA UDI | Class I | Active |
| Diamatrix Ltd. | L03420P | FDA UDI | Class I | Active |
| Diamatrix | H215-S-T | FDA UDI | Class I | Active |
| Diamatrix | H995-10S | FDA UDI | Class I | Active |
| Inami & Co., Ltd. | M-2215R | FDA UDI | Class I | Active |
| Diamatrix | H410-L-T | FDA UDI | Class I | Active |
| Diamatrix Ltd. | H170-A-D | FDA UDI | Class I | Active |
| Diamatrix Ltd. | G350C | FDA UDI | Class I | Active |
| Diamatrix | DPXT04 | FDA UDI | U | Active |
| Diamatrix | L03410.7E | FDA UDI | Class I | Active |
| ExactEtch | 2330K | FDA UDI | Class I | Active |
| Diamatrix | H330-S | FDA UDI | Class I | Active |
| Diamatrix | H105-S | FDA UDI | Class I | Active |
| ExactEtch | 2510K | FDA UDI | Class I | Active |
| Diamatrix | H215-C-S | FDA UDI | Class I | Active |
| Diamatrix Ltd. | N20-SL | FDA UDI | Class I | Active |
| Diamatrix | F855S | FDA UDI | Class I | Unknown |
| Diamatrix | C152S | FDA UDI | Class I | Active |
| Diamatrix Ltd | H320-10-S | FDA UDI | Class I | Active |
| Diamatrix | C379 | FDA UDI | Class I | Active |
| ProTekt | PG 44585MU | FDA UDI | Class I | Active |
| ExactEtch | 2210K | FDA UDI | Class I | Active |
| ProTekt | PG 44545SS | FDA UDI | Class I | Active |
| Diamatrix | F630S-V | FDA UDI | Class I | Active |
| Diamatrix | C450-23 | FDA UDI | Class I | Active |
| Diamatrix Ltd. | F869T-S | FDA UDI | Class I | Active |
| Diamatrix | M03F-9 | FDA UDI | Class I | Active |
| Diamatrix | H735 | FDA UDI | Class I | Active |
| ExactEtch | 2374K | FDA UDI | Class I | Active |
| Diamatrix | F724S-.25 | FDA UDI | Class I | Active |
| Diamatrix Ltd. | F402S | FDA UDI | Class I | Active |
| Diamatrix | N22-C | FDA UDI | Class I | Active |
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