Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat SIDAM SRL makes
The company manufactures battery-powered tissue morcellation handpieces, specifically the Cyber Blade, designed for surgical procedures requiring tissue fragmentation. It also produces a dedicated battery charger for these noninvasive devices, ensuring compatibility and safe operation.
These devices are classified as Class II under regulatory standards, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory requirements for medical device authorisation.
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 SIDAM SRL manufacture?
SIDAM SRL specializes in battery-powered surgical devices, primarily the Cyber Blade, which is a tissue morcellation handpiece. This device is used in procedures where tissue must be fragmented. Additionally, the company produces a noninvasive battery charger designed specifically for these handpieces to ensure proper charging and safe operation.
Where is SIDAM SRL based, and does that affect its regulatory standing?
SIDAM SRL is based in the United States. While the company’s location influences the regulatory framework it follows—such as FDA requirements—the specific regulatory status of its devices depends on individual authorisation processes for each product, not the company itself.
How are SIDAM SRL’s devices classified under regulatory standards?
SIDAM SRL’s devices, including the Cyber Blade tissue morcellation handpiece and its battery charger, are classified as Class II under regulatory standards. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness.
Which regulatory registries list SIDAM SRL’s devices?
SIDAM SRL’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices through a standardized identification system, ensuring transparency and traceability in the regulatory process.
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
- 443780226
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cyber Blade | 20049001 | FDA UDI | Class II | Active |
| Cyber Blade | 20041001 | FDA UDI | Class II | Active |
| Cyber Blade | 20042001 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Sidam Srl Mirandola Modena · IT FEI 3005441393