Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat TissueGUARD GmbH makes
TissueGUARD GmbH manufactures single-use surgical instrument guards designed to protect tissues during procedures, as well as non-medicated, single-use ophthalmic surgical procedure kits. These products are intended for use in controlled surgical environments to reduce contamination risk and improve procedural safety.
The company’s products fall under Class I devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The portfolio is regulated under US medical device laws, with compliance requirements aligned with FDA clearance standards.
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 TissueGUARD GmbH manufacture?
TissueGUARD GmbH specializes in single-use medical devices. Their primary products include surgical instrument guards, which protect tissues during surgical procedures, and non-medicated, single-use ophthalmic surgical procedure kits. These devices are designed to minimize contamination risks and enhance safety in controlled surgical settings.
Where is TissueGUARD GmbH based?
TissueGUARD GmbH is based in the United States. The company’s operations and regulatory compliance are aligned with US medical device laws, ensuring its products meet applicable standards for safety and performance.
Which regulatory registries list TissueGUARD GmbH’s devices?
TissueGUARD GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products, ensuring transparency and traceability in compliance with US medical device regulations.
How are TissueGUARD GmbH’s devices classified under medical device regulations?
TissueGUARD GmbH’s devices fall under Class I classification, which is the lowest risk category for medical devices in the US regulatory system. This classification applies to products like single-use surgical instrument guards and non-medicated ophthalmic kits, where the risk to patients is minimal and compliance requirements are generally less stringent than higher-risk classes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- tissueguard.de
- —
- —
- [email protected]
- Phone
- +4935146531265
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 315250714
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TissueGUARD | Tip Closure Cap for DMEK Injector | FDA UDI | Class I | Active |
| TissueGUARD | DMEK Injector SET | FDA UDI | Class I | Active |
| TissueGUARD | DMEK/DSAEK Washing GUARD | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.