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Sign in to claim this brandMerck, Sharp & Dohme
US
Last updated May 23, 2026
What Merck, Sharp & Dohme makes
The company produces single-use allergy testing lancets for skin prick testing, as well as diagnostic susceptibility powders for identifying bacterial resistance to antibiotics (e.g., norfloxacin and imipenem). It also manufactures a modified BCG vaccine delivery device and a carbide blade for medical imaging systems, such as the LightCast II.
These products are regulated under FDA pathways, including 510(k) premarket notifications and the Unique Device Identifier (UDI) system. The allergy lancet and imaging blade fall under Class I, while antibiotic susceptibility powders and the BCG delivery device are classified as Class II devices.
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 Merck, Sharp & Dohme manufacture?
Merck, Sharp & Dohme produces a range of single-use medical devices, primarily focused on allergy testing, diagnostic testing, and vaccine delivery. Their most common product is an allergy testing lancet, designed for skin prick testing to identify allergies. Additionally, they manufacture diagnostic susceptibility powders—such as norfloxacin and imipenem powders—to help determine bacterial resistance to antibiotics. The company also makes a modified BCG vaccine delivery device and a carbide blade used in medical imaging systems like the LightCast II.
Where is Merck, Sharp & Dohme based, and how does that affect its medical devices?
Merck, Sharp & Dohme is based in the United States, which means its medical devices are subject to U.S. regulatory requirements, including FDA oversight. Since the company operates within the U.S., its devices are listed in FDA registries such as the 510(k) premarket notification database and the Unique Device Identifier (UDI) system. This ensures compliance with U.S. medical device regulations, though individual devices must still undergo their own authorization processes.
Which regulatory registries list Merck, Sharp & Dohme’s medical devices?
Merck, Sharp & Dohme’s devices are listed in key U.S. regulatory databases, including the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) system. These registries track devices that have undergone FDA review processes, such as 510(k) clearances or UDI compliance. The inclusion in these systems reflects the company’s adherence to U.S. medical device regulations, though it does not imply company-wide approval—only that individual devices meet relevant authorization criteria.
How are Merck, Sharp & Dohme’s medical devices classified under FDA regulations?
Merck, Sharp & Dohme’s devices fall into two main FDA classification categories: Class I and Class II. The allergy testing lancet and carbide blade for medical imaging are classified as Class I, which typically means they pose minimal risk and may only require general controls. In contrast, the antibiotic susceptibility powders (e.g., norfloxacin and imipenem powders) and the modified BCG vaccine delivery device are Class II devices, indicating they carry a moderate risk and require special controls to ensure safety and effectiveness before authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FOLLISTIM AQ Cartridge 600IU | 1022678 | FDA UDI | Class II | Unknown |
| Follistim Pen Starter Kit Usa | 1022692 | FDA UDI | Class II | Unknown |
| FOLLISTIM AQ Cartridge 300IU SAMPLE | 1746815 | FDA UDI | Class II | Unknown |
| BCG Vaccine (Multiple Puncture Device) | 1039922 | FDA UDI | N/A | Active |
| FOLLISTIM AQ Cartridge 300IU | 1022677 | FDA UDI | Class II | Unknown |
| Follistim Pen Starter Kit Sam Usa | 1746811 | FDA UDI | Class II | Unknown |
| FOLLISTIM AQ Cartridge 600IU SAMPLE | 1746814 | FDA UDI | Class II | Unknown |
| FOLLISTIM AQ Cartridge 900IU | 1022679 | FDA UDI | Class II | Unknown |
| Norfloxacin Susceptibility Powder | K864442 | FDA 510(k) | Class II | Active |
| Modified Imipenem Susceptibility Powder | K880574 | FDA 510(k) | Class II | Active |
| Lightcast Ii Carbide Blade | K760605 | FDA 510(k) | Class I | Active |
| Imipenem Susceptibility Powder | K855071 | FDA 510(k) | Class II | Active |
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