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Sign in to claim this brandPlanatome, LLC
US
Last updated May 25, 2026
What Planatome, LLC makes
Planatome, LLC manufactures single-use manual scalpel blades designed for surgical procedures. These blades are intended for general cutting applications in operating room settings, providing disposable precision tools for medical professionals.
The company’s products fall under FDA Class I medical devices and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer 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 Planatome, LLC manufacture?
Planatome, LLC specializes in single-use manual scalpel blades. These blades are designed for surgical cutting in operating room environments, offering disposable precision tools for medical professionals. The company’s focus is on providing straightforward, reusable-free solutions for general surgical procedures.
Where is Planatome, LLC based?
Planatome, LLC is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards and facilitates its operations within the American healthcare system.
Which regulatory registries list Planatome, LLC’s devices?
Planatome, LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices like their single-use scalpel blades, ensuring transparency and traceability in the healthcare supply chain.
How are Planatome, LLC’s devices classified by regulatory authorities?
Planatome, LLC’s devices fall under FDA Class I classification. This classification is assigned to low-risk medical devices that pose minimal potential harm to users, such as single-use manual scalpel blades. Class I devices typically require less stringent regulatory oversight compared to higher-risk categories.
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
- —
- DUNS Number
- 080998543
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Planatome® | GY-10 | FDA UDI | Class I | Active |
| Planatome® | PL-10 | FDA UDI | Class I | Active |
| Planatome® | PL-11 | FDA UDI | Class I | Active |
| Planatome® | UF-15 | FDA UDI | Class I | Active |
| Planatome® | GY-15 | FDA UDI | Class I | Active |
| Planatome® | UF-10 | FDA UDI | Class I | Active |
| Planatome® | PL-15C | FDA UDI | Class I | Active |
| Planatome® | PL-15 | FDA UDI | Class I | Active |
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