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Sign in to claim this brandWhat Munich Surgical Imaging GmbH makes
Munich Surgical Imaging GmbH manufactures ophthalmic surgical microscopes, including reusable and digital binocular modules such as the SeeLuma system. Their portfolio includes sterilizable caps, standalone binoculars, and upgrade kits designed for use in eye surgery. These devices are intended to enhance visualization and precision during procedures.
The company’s products fall under FDA Class I medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to regulatory requirements for surgical imaging equipment in ophthalmology.
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 Munich Surgical Imaging GmbH manufacture?
Munich Surgical Imaging GmbH specializes in ophthalmic surgical microscopes and related components. Their primary focus is on reusable and digital binocular modules, such as the SeeLuma system, which includes sterilizable caps, standalone binoculars, and upgrade kits. These devices are designed to improve visualization and precision during eye surgery procedures.
Where is Munich Surgical Imaging GmbH based?
The company is based in the United States. This location ensures compliance with U.S. regulatory standards for medical devices, particularly those used in surgical imaging for ophthalmology.
Which regulatory registries list Munich Surgical Imaging GmbH’s devices?
Munich Surgical Imaging GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class I ophthalmic surgical microscopes and associated components, ensuring transparency and traceability in the medical device supply chain.
How are Munich Surgical Imaging GmbH’s devices classified by regulatory authorities?
The company’s devices fall under FDA Class I classification. This classification is typically assigned to low-risk medical devices, such as ophthalmic surgical microscopes and their accessories, where the risk to patients is minimal and the devices do not require stringent pre-market approval processes.
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
- 315155571
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SeeLuma Re-Sterilizable Caps | V10062-01 | FDA UDI | Class I | Active |
| SeeLuma Digital Binoculars Module | V12201-01 | FDA UDI | Class I | Active |
| SeeLuma | V12100-01 | FDA UDI | Class I | Active |
| SeeLuma Digital Binoculars Module | V12201-02 | FDA UDI | Class I | Active |
| SeeLuma | V10760-01 | FDA UDI | Class I | Active |
| SeeLuma Binoculars | V10058-01 | FDA UDI | Class I | Active |
| SeeLuma Digital Binoculars Upgrade Kit | V12203-01 | FDA UDI | Class I | Active |
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