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Sign in to claim this brandWhat ANTEIS SA makes
The company produces dermal tissue reconstructive materials derived from microbial sources, designed for soft tissue augmentation and facial contouring. These include formulations with and without lidocaine for local anaesthetic effects, intended for subcutaneous injection in cosmetic or reconstructive procedures.
All listed devices fall under Class III regulatory classification in the US and are registered in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from 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 Anteis SA manufacture?
Anteis SA specializes in dermal tissue reconstructive materials derived from microbial sources. These products are primarily used for soft tissue augmentation and facial contouring, often administered via subcutaneous injection. Their portfolio includes formulations with and without lidocaine, an anaesthetic, to provide local numbing effects during procedures.
Where is Anteis SA based, and what regulatory region does it operate in?
Anteis SA is based in the United States. The company’s devices are designed and manufactured with compliance in mind for US regulatory requirements, as evidenced by their registration in the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries list Anteis SA’s devices, and why?
Anteis SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is mandatory for Class III devices in the US, which require stringent premarket approval due to their higher risk profile and intended use in procedures like soft tissue augmentation.
How are Anteis SA’s devices classified under US regulations?
Anteis SA’s devices fall under Class III classification in the US. This classification applies to products that support or sustain life, are of substantial importance in preventing impairment or dysfunction, or present a potential unreasonable risk of illness or injury. Since these materials are used for facial contouring and tissue augmentation, they require rigorous evaluation to ensure safety and efficacy.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- merz.com
- —
- —
- [email protected]
- Phone
- 888-972-4588
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 482133837
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Belotero Balance (+) Lidocaine | 8710M0 | FDA UDI | Class III | Active |
| Belotero Balance (+) Lidocaine | 8710M0S | FDA UDI | Class III | Active |
| Belotero Balance | 8700M0 | FDA UDI | Class III | Active |
| Belotero Balance (+) Lidocaine | 8705M0S | FDA UDI | Class III | Active |
| Belotero Balance | 8706M0 | FDA UDI | Class III | Active |
| Belotero Balance (+) Lidocaine | 8705M0 | FDA UDI | Class III | Active |
| Belotero Balance | 8700M0S | FDA UDI | Class III | Active |
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