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Sign in to claim this brandUnimicro Medical Systems (ShenZhen) Co., Ltd.
US
Last updated May 30, 2026
What Unimicro Medical Systems (ShenZhen) Co., Ltd. makes
Unimicro Medical Systems produces single-use laparoscopic and endoscopic instruments, including trocars (both visible and bladeless), monopolar electrosurgical electrodes and handpieces, and tissue extraction bags. Their portfolio covers forceps (Babcock, grasping, atraumatic intestinal, and uterus-specific), graspers, and straight scissors designed for minimally invasive surgical procedures. Devices are intended for tissue manipulation, dissection, and electrosurgical applications in laparoscopic and endoscopic surgeries.
All listed devices fall under Class II regulatory classification in the US and are recorded in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable US regulatory requirements for medical devices.
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 Unimicro Medical Systems primarily manufacture?
Unimicro Medical Systems specializes in single-use laparoscopic and endoscopic instruments. Their portfolio includes laparoscopic access cannulas (such as visible and bladeless trocars), monopolar electrosurgical electrodes and handpieces, tissue extraction bags, and various forceps (including Babcock, grasping, atraumatic intestinal, and uterus-specific). These devices are designed for minimally invasive surgeries, enabling tissue manipulation, dissection, and electrosurgical applications.
Where is Unimicro Medical Systems based, and how does this affect its regulatory compliance?
Unimicro Medical Systems is based in the United States. As a US-based manufacturer, the company must comply with applicable US regulatory requirements for medical devices, including those governing design, manufacturing, and post-market surveillance. This ensures their devices meet the necessary standards for safety, performance, and regulatory listing.
Which regulatory registries or databases list Unimicro Medical Systems’ devices?
Unimicro Medical Systems’ devices are recorded in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in regulatory oversight. This listing is specific to individual devices, not the company itself.
How are Unimicro Medical Systems’ devices classified under US regulations?
All of Unimicro Medical Systems’ listed devices fall under Class II regulatory classification in the US. Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification influences the regulatory pathway and post-market requirements for these products.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 421327368
Catalogue (46)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Visible Trocar | UNTR-C1510 | FDA UDI | Class II | Active |
| Disposable Monopolar Babcock Forceps | MBK505330 | FDA UDI | Class II | Active |
| Disposable Monopolar Grasper Forceps | MGP305330 | FDA UDI | Class II | Active |
| Auto-locking Trocar | UNTR-A1010 | FDA UDI | Class II | Active |
| Disposable Monopolar Atraumatic Intestinal Forceps | MAI905330 | FDA UDI | Class II | Active |
| Disposable Monopolar Straight Scissors | MMS105330 | FDA UDI | Class II | Active |
| Bladeless Trocar | BTRDFA1010 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRKFS1210 | FDA UDI | Class II | Active |
| Disposable Monopolar Uterus Grasping Forceps | MUG605330 | FDA UDI | Class II | Active |
| Visible Trocar | UNTR-C1515 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRKFA1210 | FDA UDI | Class II | Active |
| Bladeless Trocar | BTRDFS0510 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRHFS0510 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRKFA0510 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRKFS0507 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRKFS1010 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRHFA0510 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRHFS0507 | FDA UDI | Class II | Active |
| Bladeless Trocar | BTRDFS1010 | FDA UDI | Class II | Active |
| Retrieval Pouch with Introducer | MEBM400 | FDA UDI | Class II | Active |
| Bladeless Trocar | BTRDFA0510 | FDA UDI | Class II | Active |
| Bladeless Trocar | BTRDFA1210 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRHFA1010 | FDA UDI | Class II | Active |
| Retrieval Pouch with Introducer | MEBS400 | FDA UDI | Class II | Active |
| Visible Trocar | UNTR-III1210 | FDA UDI | Class II | Active |
| Visible Trocar | UNTR-C0515 | FDA UDI | Class II | Active |
| Bladeless Trocar | UNTR-B1010 | FDA UDI | Class II | Active |
| Bladeless Trocar | UNTR-B0515 | FDA UDI | Class II | Active |
| Bladeless Trocar | UNTR-B1515 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRHFS1210 | FDA UDI | Class II | Active |
| Visible Trocar | UNTR-C1010 | FDA UDI | Class II | Active |
| Disposable Monopolar Mixter Forceps | MDM805330 | FDA UDI | Class II | Active |
| Bladeless Trocar | UNTR-B1110 | FDA UDI | Class II | Active |
| Retrieval Pouch with Introducer | MEBM600 | FDA UDI | Class II | Active |
| Retrieval Pouch with Introducer | MEBS200 | FDA UDI | Class II | Active |
| Dissecting & Access Balloon Trocar | UNTD-C1210 | FDA UDI | Class II | Active |
| Bladeless Trocar | BTRDFS1210 | FDA UDI | Class II | Active |
| Disposable Monopolar Clinch Forceps | MCH405330 | FDA UDI | Class II | Active |
| Visible Trocar | VTRDSB0510 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRHFS1010 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRKFS0510 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRHFA1210 | FDA UDI | Class II | Active |
| Disposable Monopolar Curved Scissors | MMS205330 | FDA UDI | Class II | Active |
| Auto-locking Trocar | ATRKFA1010 | FDA UDI | Class II | Active |
| Disposable Monopolar Dissector Forceps | MDS705330 | FDA UDI | Class II | Active |
| Pediatric Trocar | UNTR-IV0406 | FDA UDI | Class II | Active |
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