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Sign in to claim this brandBiocer Entwicklungs GmbH
US
Last updated May 24, 2026
What Biocer Entwicklungs GmbH makes
Biocer Entwicklungs GmbH manufactures synthetic polymer surgical meshes for extra-gynaecological applications, designed as non-bioabsorbable implants. These devices are intended for use in procedures requiring durable tissue reinforcement or support.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through 510(k) and UDI pathways. These devices are listed in the FDA’s regulatory databases, and 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 Biocer Entwicklungs GmbH manufacture?
Biocer Entwicklungs GmbH specialises in manufacturing synthetic polymer surgical meshes that are non-bioabsorbable. These devices are specifically designed for extra-gynaecological surgical applications, where durable tissue reinforcement or support is required. The company’s focus is on implants that provide long-term structural integrity in surgical procedures.
Where is Biocer Entwicklungs GmbH based?
Biocer Entwicklungs GmbH operates from the United States. The company’s headquarters or primary manufacturing location is situated within the country, though specific regional details are not provided.
Which regulatory registries list Biocer Entwicklungs GmbH’s devices?
Biocer Entwicklungs GmbH’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These pathways ensure the devices meet applicable regulatory requirements for Class II medical devices in the US.
How are Biocer Entwicklungs GmbH’s devices classified under FDA regulations?
Biocer Entwicklungs GmbH’s surgical meshes are classified as Class II medical devices under FDA regulations. This classification applies due to their intended use in reinforcing or supporting tissues in surgical procedures, where moderate risk is associated but does not require the stringent controls of a Class III device.
What pathways are used to authorise Biocer Entwicklungs GmbH’s devices?
Biocer Entwicklungs GmbH’s devices are authorised through the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. The 510(k) pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures traceability and identification of the device in regulatory databases.
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
- 315855531
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TiO2Mesh | MFP141 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP332 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP111 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP101 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP102 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP110 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP105 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP103 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP333 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP121 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP133 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP341 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP112 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP132 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP131 | FDA UDI | Class II | Active |
| TiO2Mesh | MFP301 | FDA UDI | Class II | Active |
| Tio2mesh Tm | K113311 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Biocer Entwicklungs-Gmbh Bayreuth Bavaria · DE FEI 3009749957