Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Arcera GmbH makes
Arcera GmbH manufactures synovial fluid supplementation media designed for intra-articular joint injections, including hyaluronic acid-based viscosupplements for osteoarthritis treatment. These products are formulated to restore joint lubrication and cushioning, aiding mobility in affected joints.
The company’s portfolio is classified under FDA’s Class III medical devices and is registered in the FDA’s Unique Device Identifier (UDI) database. The products are intended for use in the United States, adhering to regulatory requirements for high-risk, life-sustaining or life-supporting devices.
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 Arcera GmbH manufacture?
Arcera GmbH specializes in synovial fluid supplementation media, specifically hyaluronic acid-based viscosupplements. These devices are formulated for intra-articular joint injections and are primarily used to treat osteoarthritis by restoring joint lubrication and cushioning, thereby improving mobility in affected joints.
Where is Arcera GmbH based, and where are its devices intended for use?
Arcera GmbH is based in the United States. Its devices are designed and intended for use within the U.S. regulatory framework, adhering to the requirements for medical products in that market.
Which regulatory registries list Arcera GmbH’s devices?
Arcera GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring traceability and compliance with regulatory standards.
How are Arcera GmbH’s devices classified under FDA regulations?
Arcera GmbH’s devices fall under FDA’s Class III classification. This category includes high-risk medical devices that are intended to sustain or support life, or are of substantial importance in preventing impairment of human health. Examples include its hyaluronic acid-based viscosupplements, which require stringent regulatory oversight due to their potential impact on patient safety and treatment outcomes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 341558403
Catalogue (7)
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.