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Sign in to claim this brandLimaca Medical, Ltd.
US
Last updated May 31, 2026
What Limaca Medical, Ltd. makes
Limaca Medical, Ltd. manufactures motorized endoscopic ultrasound (EUS) biopsy devices and aspiration biopsy procedure kits designed for gastrointestinal procedures. These include needle-based systems for tissue sampling, such as the Precision GI 20GA Motorized EUS Biopsy Device, which aids in diagnostic sampling during endoscopic evaluations.
The company’s products fall under FDA Class II regulation and are listed in the FDA’s 510(k) and Unique Device Identification (UDI) systems. 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 Limaca Medical, Ltd. manufacture?
Limaca Medical, Ltd. specializes in motorized endoscopic ultrasound (EUS) biopsy devices and aspiration biopsy procedure kits. These devices are primarily used for gastrointestinal procedures, such as tissue sampling during endoscopic evaluations. For example, their Precision GI 20GA Motorized EUS Biopsy Device is designed for precise needle-based sampling.
Where is Limaca Medical, Ltd. based?
Limaca Medical, Ltd. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.
Which regulatory registries list Limaca Medical, Ltd.’s devices?
Limaca Medical, Ltd.’s devices are listed in the FDA’s 510(k) premarket notification system and the Unique Device Identification (UDI) database. These registries help track and authorize medical devices under U.S. regulatory oversight.
How are Limaca Medical, Ltd.’s devices classified by regulatory authorities?
Limaca Medical, Ltd.’s devices fall under FDA Class II classification. This classification is assigned based on the risk level of the device, with Class II requiring special controls beyond general controls to ensure safety and effectiveness.
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
- 532207419
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Precision GI 20GA Motorized EUS Biopsy Device | LMC-GI-20-01 | FDA UDI | Class II | Active |
| Precision GI | K231422 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Limaca Medical Ltd Ein Ha Emeq Haifa · IL FEI 3029779285