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Sign in to claim this brandSPATZ FGIA (ISRAEL) LTD
US
Last updated May 27, 2026
What SPATZ FGIA (ISRAEL) LTD makes
The company manufactures an adjustable gastric balloon system designed for temporary weight management, including kits for insertion, adjustment, and extraction of the balloon within the stomach. The device is intended for use in clinical settings to support patients undergoing obesity treatment.
The portfolio is classified as Class III under FDA regulations and is listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from 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 Spatz FGIA (Israel) Ltd manufacture?
Spatz FGIA (Israel) Ltd manufactures an adjustable gastric balloon system designed for temporary weight management. This includes kits for inserting, adjusting, and removing the balloon inside the stomach. The device is intended for use in clinical settings to support patients undergoing obesity treatment.
Where is Spatz FGIA (Israel) Ltd based?
The company operates from the United States, though its legal entity is registered in Israel. The manufacturing and distribution of its devices are conducted within the US market.
Which regulatory registries list Spatz FGIA (Israel) Ltd’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices authorised in the US.
How are Spatz FGIA (Israel) Ltd’s devices classified under FDA regulations?
The company’s adjustable gastric balloon system falls under Class III classification by the FDA. This classification applies to devices that support or sustain life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Due to its role in obesity treatment, the device requires stringent regulatory oversight.
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
- 514763510
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spatz3 Adjustable Balloon System® Adjustment/Extraction Kit | A-SP3-015 | FDA UDI | N/A | Active |
| Spatz3 Adjustable Balloon System insertion kit | A-SP3US-03K | FDA UDI | Class III | Active |
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