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Sign in to claim this brandAUROLAB
US
Last updated May 27, 2026
What AUROLAB makes
The company manufactures non-bioabsorbable monofilament nylon sutures and silk sutures, including braided and monofilament variants, used for internal and external wound closure in surgical procedures. These products are designed for general surgical applications, vascular surgery, and ophthalmic procedures, with variations in needle styles and suture sizes to accommodate different clinical needs.
The suture portfolio is regulated under FDA Class II and Class U device classifications, with submissions listed via 510(k) and Unique Device Identification (UDI) registries. The manufacturer operates from the United States, adhering to domestic regulatory requirements for medical device compliance.
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 AuroLab manufacture?
AuroLab specializes in non-bioabsorbable sutures, specifically nylon sutures (both monofilament and braided) and silk sutures. These sutures are used for internal and external wound closure in surgeries, including general surgery, vascular procedures, and ophthalmic applications. The company’s products are tailored to meet diverse clinical needs through variations in needle styles and suture sizes.
Where is AuroLab based, and how does this affect its regulatory compliance?
AuroLab is based in the United States, which means its devices must comply with FDA regulations. Since sutures fall under Class II and Class U classifications, they undergo premarket submissions like 510(k) clearances and Unique Device Identification (UDI) registration to ensure safety and effectiveness before entering the market.
Which regulatory registries list AuroLab’s devices?
AuroLab’s devices are documented in the FDA’s 510(k) and Unique Device Identification (UDI) registries. These registries track submissions and compliance data for Class II and Class U devices, ensuring transparency and adherence to U.S. medical device regulations.
How are AuroLab’s sutures classified by regulatory authorities?
AuroLab’s sutures are classified as either Class II or Class U devices by the FDA. Class II devices require special controls to ensure their safety and performance, while Class U (unclassified) devices are typically low-risk but still subject to regulatory oversight. The classification determines the submission requirements, such as 510(k) clearances or other regulatory pathways.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- aurolab.com
- —
- —
- [email protected]
- Phone
- +914523096100
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 677319965
Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aurotrocar | ATS-23G | FDA UDI | Class I | Unknown |
| Aurolon | 6401N | FDA UDI | Class II | Active |
| Cornisol | Cornisol | FDA UDI | U | Unknown |
| Aurosilk | B6106 | FDA UDI | Class II | Active |
| AuroSlim | SK22215 | FDA UDI | Class I | Unknown |
| Polycryl | A8104 | FDA UDI | Class II | Active |
| Aurosilk | 8481S | FDA UDI | Class II | Active |
| Aurolon | 8401N | FDA UDI | Class II | Active |
| Aurolon | 8492N | FDA UDI | Class II | Active |
| Nanocut | S15002 | FDA UDI | Class I | Unknown |
| Polycryl | A6409 | FDA UDI | Class II | Active |
| Aurolon | 8482N | FDA UDI | Class II | Active |
| Aurolon | 6692N | FDA UDI | Class II | Active |
| Aurolon | N6106 | FDA UDI | Class II | Active |
| Aurolon | 6601N | FDA UDI | Class II | Active |
| Aurolon | 6402N | FDA UDI | Class II | Active |
| AuroSleek | C25222HT | FDA UDI | Class I | Unknown |
| Polycryl | A7102 | FDA UDI | Class II | Active |
| Aurosilk | B4401 | FDA UDI | Class II | Active |
| Aurolon | N7202 | FDA UDI | Class II | Active |
| Aurolon | 8402N | FDA UDI | Class II | Active |
| Aurosilk | B6105 | FDA UDI | Class II | Active |
| Polycryl | A6108 | FDA UDI | Class II | Active |
| Aurolon | 8481N | FDA UDI | Class II | Active |
| Aurolon | 6602N | FDA UDI | Class II | Active |
| Aurosilk | 8482S | FDA UDI | Class II | Active |
| Cornisol | K221759 | FDA 510(k) | U | Active |
| Polycryl | K140039 | FDA 510(k)FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Aurolab MADURAI Tamil Nadu · IN FEI 3002957101