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Sign in to claim this brandBibbinstruments AB
US
Last updated May 30, 2026
What Bibbinstruments AB makes
Bibbinstruments AB manufactures single-use endoscopic needle devices designed for general-purpose biopsy procedures. Their portfolio includes the Endodrill Biopsy instrument and the EndoDrill® Model X, which are intended for minimally invasive tissue sampling during endoscopic examinations.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) and UDI registries. The company 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 Bibbinstruments AB manufacture?
Bibbinstruments AB specializes in single-use endoscopic needle devices. Their primary focus is on general-purpose endoscopic needles, which are used for minimally invasive tissue sampling during endoscopic procedures. These devices are designed to simplify biopsy workflows while maintaining precision and safety.
Where is Bibbinstruments AB based?
Bibbinstruments AB is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs the classification and listing of its devices.
Which regulatory registries list Bibbinstruments AB’s devices?
Bibbinstruments AB’s devices are included in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries help track and identify their Class II devices, ensuring compliance with regulatory requirements for endoscopic biopsy instruments.
How are Bibbinstruments AB’s devices classified under regulatory standards?
Bibbinstruments AB’s devices, such as the Endodrill Biopsy instrument and EndoDrill® Model X, fall under Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as endoscopic biopsy tools.
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
- 352499168
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Endodrill Biopsy instrument | GI 17G | FDA UDI | Class II | Active |
| Endodrill Biopsy instrument | GI 17G | FDA UDI | Class II | Active |
| EndoDrill® Model X | K212423 | FDA 510(k) | Class II | Active |
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