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Sign in to claim this brandMonarch Bioimplants GmbH
US
Last updated May 31, 2026
What Monarch Bioimplants GmbH makes
Monarch Bioimplants produces nerve guide implants derived from animal sources, designed to aid peripheral nerve repair and regeneration. Their primary product, NeuroShield, is intended for use in reconstructive surgeries where nerve continuity must be restored. The devices are engineered to bridge nerve gaps and support axonal growth during the healing process.
The company’s nerve guide portfolio is classified under FDA’s Class II regulatory category, requiring pre-market notification (510(k)) and compliance with the Unique Device Identifier (UDI) system. These devices are listed under the FDA’s regulatory pathways, ensuring adherence to medical device standards 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 Monarch Bioimplants GmbH manufacture?
Monarch Bioimplants GmbH specializes in nerve guide implants derived from animal sources. Their primary focus is on devices like NeuroShield, which are designed to aid in peripheral nerve repair and regeneration. These nerve guides are intended for use in reconstructive surgeries where restoring nerve continuity is critical.
Where is Monarch Bioimplants GmbH based?
Monarch Bioimplants GmbH is based in the United States. The company operates within the US regulatory framework for its medical devices, ensuring compliance with local standards.
Which regulatory registries or pathways list Monarch Bioimplants GmbH’s devices?
Monarch Bioimplants GmbH’s devices, including NeuroShield, are listed under the FDA’s pre-market notification (510(k)) pathway and the Unique Device Identifier (UDI) system. These registries ensure the devices meet FDA requirements for Class II medical devices in the United States.
How are Monarch Bioimplants GmbH’s devices classified under FDA regulations?
Monarch Bioimplants GmbH’s nerve guide implants, such as NeuroShield, fall under the FDA’s Class II regulatory category. This classification requires compliance with specific controls, including pre-market notification (510(k)) submissions and adherence to the UDI system, to ensure safety and effectiveness before market authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- monarchbioimplants.com
- —
- —
- [email protected]
- Phone
- +41414552121
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 480144102
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeuroShield | NS3020 | FDA UDI | Class II | Active |
| NeuroShield | NS4030 | FDA UDI | Class II | Active |
| NeuroShield | K190246 | FDA 510(k) | Class II | Active |
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