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Sign in to claim this brandBP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
US
Last updated May 23, 2026
What BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY makes
The company manufactures single-use medical gloves, including non-powdered, non-antimicrobial versions made from hevea latex, nitrile, and vinyl for surgical and examination/treatment purposes. It also produces general-purpose and radiopaque woven surgical sponges, non-adhesive device retention bandages, and non-woven gauze pads for wound care.
These products are classified under FDA’s Class I and Class II regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates within the United States, adhering to applicable U.S. medical device compliance requirements.
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 BP Pharmaceuticals Laboratories Unlimited Company manufacture?
BP Pharmaceuticals Laboratories Unlimited Company specializes in single-use medical devices primarily focused on infection control and wound care. Their product line includes surgical and examination gloves made from hevea latex, nitrile, and vinyl—all non-powdered and non-antimicrobial—along with general-purpose and radiopaque woven surgical sponges, non-adhesive device retention bandages, and non-woven gauze pads. These items are designed for use in clinical settings to reduce contamination risks and support patient care.
Where is BP Pharmaceuticals Laboratories Unlimited Company based, and how does that affect its regulatory compliance?
BP Pharmaceuticals Laboratories Unlimited Company is based in the United States. As a U.S.-based manufacturer, its devices must comply with FDA regulations, including classification under FDA’s Class I (low-risk) and Class II (moderate-risk) categories. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and adherence to U.S. medical device requirements.
Which regulatory registries or databases list BP Pharmaceuticals Laboratories Unlimited Company’s devices?
BP Pharmaceuticals Laboratories Unlimited Company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a standardized identifier to medical devices to improve tracking, transparency, and regulatory oversight. This listing helps healthcare providers and regulators verify device details, such as manufacturer information and classification.
How are BP Pharmaceuticals Laboratories Unlimited Company’s devices classified by the FDA?
The FDA classifies BP Pharmaceuticals Laboratories Unlimited Company’s devices under Class I (for low-risk items like general-purpose surgical sponges and non-woven gauze pads) and Class II (for moderate-risk items such as surgical gloves and retention bandages). Classification determines the regulatory controls applied—Class I devices typically require general controls, while Class II may involve additional performance standards or post-market surveillance 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
- 985523874
Catalogue (167)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Amerisource Bergen | 10658 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10281 | FDA UDI | Class I | Active |
| Amerisource Bergen | 10115 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10543 | FDA UDI | Class II | Active |
| AmerisourceBergen | 10243 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10546 | FDA UDI | Class II | Active |
| AmerisourceBergen | 10047 | FDA UDI | Class I | Active |
| Amerisource Bergen | 10131 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10041 | FDA UDI | Class I | Active |
| Amerisource Bergen | 10013 | FDA UDI | Class I | Unknown |
| AmerisourceBergen | 10058 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10538 | FDA UDI | Class II | Unknown |
| AmerisourceBergen | 10263 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10046 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10048 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10249 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10044 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10040 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10043 | FDA UDI | Class I | Active |
| Amerisource Bergen | 10017 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10539 | FDA UDI | Class II | Unknown |
| AmerisourceBergen | 10544 | FDA UDI | Class II | Active |
| AmerisourceBergen | 10324 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10125 | FDA UDI | Class I | Active |
| Amerisource Bergen | 10016 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10330 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10118 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10341 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10338 | FDA UDI | Class I | Active |
| Amerisource Bergen | 10010 | FDA UDI | Class I | Unknown |
| AmerisourceBergen | 10059 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10029 | FDA UDI | Class I | Unknown |
| AmerisourceBergen | 10344 | FDA UDI | Class I | Active |
| Amerisource Bergen | 10659 | FDA UDI | Class I | Active |
| AmerisourceBergen | 11207 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10327 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10268 | FDA UDI | Class I | Active |
| Amerisource Bergen | 10128 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10282 | FDA UDI | Class I | Active |
| AmerisourceBergen | 11504 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10278 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10032 | FDA UDI | Class I | Unknown |
| AmerisourceBergen | 10060 | FDA UDI | Class I | Active |
| AmerisourceBergen | DMT-4333 | FDA UDI | Class II | Active |
| Amerisource Bergen | 10011 | FDA UDI | Class I | Unknown |
| AmerisourceBergen | 10020 | FDA UDI | Class I | Active |
| Amerisource Bergen | 10803 | FDA UDI | Class I | Active |
| AmerisourceBergen | 11201 | FDA UDI | Class I | Active |
| AmerisourceBergen | 10248 | FDA UDI | Class I | Active |
| Amerisource Bergen | 10129 | FDA UDI | Class I | Active |
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