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Sign in to claim this brandB. Ali Impex
US
Last updated May 23, 2026
What B. Ali Impex makes
B. Ali Impex manufactures single-use and reusable dental and ophthalmic surgical instruments, including pellet implantation cannulas, rubber dam clamps, manual dental scalers, tooth extraction forceps, suturing needle holders, blepharoplasty scissors, dental mirrors, and facebows. Their product line also includes reusable dental tools like the Nivo, Doctor Nice, and ECCO series, designed for precision in oral and maxillofacial procedures.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable 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 B. Ali Impex manufacture?
B. Ali Impex specializes in dental and ophthalmic surgical instruments, producing both single-use and reusable devices. Their product line includes items like pellet implantation cannulas, rubber dam clamps, manual dental scalers, tooth extraction forceps, suturing needle holders, blepharoplasty scissors, dental mirrors, and facebows. These tools are designed for precision in oral and maxillofacial procedures, ensuring functionality in clinical settings.
Where is B. Ali Impex based, and does this affect their regulatory compliance?
B. Ali Impex is based in the United States. Since the company operates within the U.S., its devices must comply with FDA regulations, including classification under FDA’s Class I or Class II categories and listing in the FDA’s Unique Device Identifier (UDI) database. This ensures adherence to U.S. medical device standards and transparency in the regulatory system.
Which regulatory registries list B. Ali Impex’s devices?
B. Ali Impex’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance with regulatory requirements. The UDI system helps healthcare providers and regulators verify device details, including classification and manufacturer information.
How are B. Ali Impex’s devices classified under FDA regulations?
B. Ali Impex’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s purpose, potential risks, and intended use in clinical settings, as outlined in FDA guidelines.
What does it mean for B. Ali Impex’s devices to be listed in the FDA’s UDI database?
Listing in the FDA’s UDI database means each of B. Ali Impex’s devices has a unique identifier assigned to it, ensuring clear and standardized tracking. This system helps healthcare professionals, regulators, and supply chain partners quickly locate device information, verify compliance, and manage recalls if necessary. The UDI system enhances transparency and accountability in the medical device lifecycle.
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
- 645802117
Catalogue (89)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nivo | NB2729 | FDA UDI | Class I | Active |
| Nivo | NEEDG16 | FDA UDI | Class I | Active |
| Doctor Nice | 490.315 | FDA UDI | Class I | Active |
| Doctor Nice | 786-15G4 | FDA UDI | Class II | Active |
| Doctor Nice | 14-2487-20 | FDA UDI | Class I | Active |
| Doctor Nice | 786-21G2 | FDA UDI | Class II | Active |
| Doctor Nice | 786-14G4 | FDA UDI | Class II | Active |
| Nivo | NRDC27AW | FDA UDI | Class I | Active |
| Nivo | NGS1314 | FDA UDI | Class I | Active |
| Doctor Nice | 113703 | FDA UDI | Class I | Active |
| Doctor Nice | 786-04 | FDA UDI | Class II | Active |
| Nivo | NMCS4 | FDA UDI | Class I | Active |
| Doctor Nice | 786-15 | FDA UDI | Class II | Active |
| Nivo | NPF12 | FDA UDI | Class I | Active |
| Shark | 115364 | FDA UDI | Class I | Active |
| Nivo | NASCW | FDA UDI | Class I | Active |
| Nivo | NRDC13AW | FDA UDI | Class I | Active |
| Nivo | NF151S | FDA UDI | Class I | Active |
| Doctor Nice | 786-05 | FDA UDI | Class II | Active |
| Nivo | NE5DE | FDA UDI | Class I | Active |
| Nivo | NSS204S | FDA UDI | Class I | Active |
| Nivo | NISC45 | FDA UDI | Class I | Active |
| Nivo | NES301 | FDA UDI | Class I | Active |
| Doctor Nice | 113979 | FDA UDI | Class I | Active |
| Nivo | NISS45 | FDA UDI | Class I | Active |
| Doctor Nice | 102434 | FDA UDI | Class I | Active |
| Nivo | NCWNH6 | FDA UDI | Class I | Active |
| Doctor Nice | 786-28 | FDA UDI | Class II | Active |
| Doctor Nice | 3757128 | FDA UDI | Class I | Active |
| Doctor Nice | Suturing needle holder, reusable | FDA UDI | Class I | Active |
| Doctor Nice | 420971 | FDA UDI | Class I | Active |
| Doctor Nice | 786-28L10 | FDA UDI | Class II | Active |
| Nivo | NLK7R | FDA UDI | Class I | Active |
| Nivo | NRDC27W | FDA UDI | Class I | Active |
| Nivo | NES23 | FDA UDI | Class I | Active |
| Doctor Nice | 786-04G3 | FDA UDI | Class II | Active |
| Nivo | NCPL317 | FDA UDI | Class I | Active |
| Nivo | NRDC2AW | FDA UDI | Class I | Active |
| Nivo | NWPF12 | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- B. Ali Impex SIALKOT, Punjab · PK FEI 3003882387