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Sign in to claim this brandMT.DERM GmbH
US
Last updated May 25, 2026
What MT.DERM GmbH makes
MT.DERM GmbH manufactures electronic micro-needling devices designed for professional cosmetic use, including handheld handpieces and disposable cartridge systems. These devices are intended for controlled skin penetration to promote collagen production and improve texture, with models such as the Exceed series and safety needle cartridges. Footswitches are also part of the portfolio, enabling hands-free operation during procedures.
The company’s devices fall under FDA Class II regulation, with authorisation via 510(k) premarket notifications and inclusion in the FDA’s Unique Device Identifier (UDI) database. These products are listed under the FDA’s regulatory framework and are intended for use 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 MT.DERM GmbH manufacture?
MT.DERM GmbH specializes in professional cosmetic micro-needling devices. Their portfolio includes electronic handheld handpieces, disposable cartridge systems (like the Exceed series), and safety needle cartridges designed for controlled skin penetration. These devices are intended to stimulate collagen production and improve skin texture. Footswitches are also part of their offerings, allowing for hands-free operation during procedures.
Where is MT.DERM GmbH based, and what regulatory framework applies to their devices?
MT.DERM GmbH is based in the United States. Their devices fall under FDA Class II regulation, which applies to moderate-risk medical products requiring special controls to ensure safety and effectiveness. This classification means their devices undergo premarket notification (510(k)) review and are listed in the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries or databases list MT.DERM GmbH’s devices?
MT.DERM GmbH’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries ensure transparency and compliance with U.S. regulatory requirements for Class II devices.
How are MT.DERM GmbH’s micro-needling devices classified by the FDA?
MT.DERM GmbH’s micro-needling devices are classified as FDA Class II. This classification is based on their intended use—professional cosmetic procedures involving controlled skin penetration—and the associated moderate risk. Class II devices require special controls beyond general controls to mitigate risks, such as premarket notifications (510(k)) and compliance with UDI requirements.
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
- 329216357
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Footswitch | E104802USMP | FDA UDI | Class II | Active |
| Exceed | AD61USMP | FDA UDI | Class II | Unknown |
| Exceed | AD64801USMP | FDA UDI | Class II | Active |
| Exceed | AD61USMP | FDA UDI | Class II | Unknown |
| Footswitch | E100201USMP | FDA UDI | Class II | Unknown |
| Safety Needle Cartridge 6-MNP 1.5 Exceed US | EMNPAED06USMP | FDA UDI | Class II | Unknown |
| Footswitch | E104201USMP | FDA UDI | Class II | Active |
| Exceed | AD64201USMP | FDA UDI | Class II | Active |
| Safety Needle Cartridge 6-MNP 1.5 Exceed US | EMNPA4206USMP | FDA UDI | Class II | Active |
| Safety Needle Cartridge 6-MNP 1.5 Exceed US | EMNPA4806USMP | FDA UDI | Class II | Active |
| Footswitch | E100201USMP | FDA UDI | Class II | Unknown |
| Exceed Microneedling Device | K180778 | FDA 510(k) | Class II | Active |
| Exceed Microneedling device | K182407 | FDA 510(k) | Class II | Active |
| Exceed Unlimited | K233709 | FDA 510(k) | Class II | Active |
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