Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Hans Biomed Corporation makes
Hans Biomed Corporation manufactures human-derived bone matrix implants for orthopedic and dental applications, including putty formulations and allograft-based products. Their portfolio also includes bioabsorbable polyester sutures and monofilament lift threads designed for soft tissue support. These devices are intended for bone regeneration, grafting, and surgical fixation procedures.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) and UDI registrations. Their products are authorised for use in the United States, where the manufacturer is based.
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 Hans Biomed Corporation manufacture?
Hans Biomed Corporation specializes in human-derived bone matrix implants, including products like putty formulations and allograft-based materials. Their portfolio also covers bioabsorbable polyester sutures and monofilament lift threads, which are designed for soft tissue support. These devices are primarily used in orthopedic and dental procedures for bone regeneration, grafting, and surgical fixation.
Where is Hans Biomed Corporation based, and where are its devices authorised for use?
Hans Biomed Corporation is based in the United States. Their devices are authorised for use in the US, where they are regulated under FDA guidelines. The company’s products are classified as Class II, indicating they pose moderate risk and require specific regulatory pathways like 510(k) clearance and UDI registration.
Which regulatory registries list Hans Biomed Corporation’s devices?
Hans Biomed Corporation’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with US regulatory requirements for Class II medical devices, which include bone matrix implants and bioabsorbable sutures.
How are Hans Biomed Corporation’s devices classified under FDA regulations?
Hans Biomed Corporation’s devices are classified as Class II under FDA regulations. This classification applies to products that generally pose moderate risk to patients and require special controls beyond general controls to ensure safety and effectiveness. Examples include bone matrix implants and bioabsorbable sutures, which undergo 510(k) clearance to demonstrate their compliance with regulatory standards.
What is the reasoning behind the FDA classification of Hans Biomed Corporation’s devices?
The FDA classifies Hans Biomed’s devices as Class II because they are intended for procedures involving bone regeneration, grafting, or soft tissue support, where moderate risks—such as improper placement or adverse tissue reactions—could occur. Class II classification requires manufacturers to submit a 510(k) premarket submission to demonstrate that their devices are substantially equivalent to legally marketed predicates, ensuring they meet performance and safety standards without the higher scrutiny of Class III devices.
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
- —
Catalogue (161)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mint | MINT 14WC1985 | FDA UDI | Class II | Active |
| ExFuse | EP10 | FDA UDI | Class II | Active |
| C-Graft Putty | CG-P03 | FDA UDI | Class II | Active |
| TruForm | FG100DEMO | FDA UDI | Class II | Active |
| TruForm | FP010 | FDA UDI | Class II | Active |
| TruForm | FP0100DEMO | FDA UDI | Class II | Active |
| TruForm+ | TFP010DEMO | FDA UDI | Class II | Active |
| Mint | MINT 95LC1960 | FDA UDI | Class II | Active |
| SurFuse | SP03 | FDA UDI | Class II | Active |
| TruForm+ | TFP050 | FDA UDI | Class II | Active |
| ExFuse | EG8 | FDA UDI | Class II | Active |
| SurFuse | SG5 | FDA UDI | Class II | Active |
| BellaFuse | D25.100D | FDA UDI | Class II | Active |
| C-Graft Putty | CG-P100 | FDA UDI | Class II | Active |
| TruForm | FP050 | FDA UDI | Class II | Active |
| BellaFuse | D1.4D | FDA UDI | Class II | Active |
| Mint | MINT-I 15WC1985 | FDA UDI | Class II | Active |
| SurFuse | SP5 | FDA UDI | Class II | Active |
| CureMix Plus | 2016-0010 | FDA UDI | Class II | Active |
| ExFuse | EP3 | FDA UDI | Class II | Active |
| Mint Lift | MINT 43BN1913 | FDA UDI | Class II | Active |
| TruForm | FP030 | FDA UDI | Class II | Active |
| MaxiGen | MGP05 | FDA UDI | Class II | Active |
| TruForm | FP003 | FDA UDI | Class II | Active |
| TruForm | FP030DEMO | FDA UDI | Class II | Active |
| Mint | MINI-S 1017 | FDA UDI | Class II | Active |
| SurFuse | SG3 | FDA UDI | Class II | Active |
| ExFuse | EP1 | FDA UDI | Class II | Active |
| alloOss Allograft Putty | 01105002 | FDA UDI | Class II | Active |
| Vivex DBM Plus | VX-EP5 | FDA UDI | Class II | Active |
| SurFuse | SP05 | FDA UDI | Class II | Active |
| Vivex DBM Plus | VX-EP1 | FDA UDI | Class II | Active |
| TruForm | FG050DEMO | FDA UDI | Class II | Active |
| MaxiGen | MGP10 | FDA UDI | Class II | Active |
| Mint | ML1043 | FDA UDI | Class II | Active |
| Exponent | EXP00 | FDA UDI | Class II | Active |
| C-Graft Putty | CG-P50 | FDA UDI | Class II | Active |
| BellaFuse | DBF250 | FDA UDI | Class II | Active |
| TruForm+ | TFG030DEMO | FDA UDI | Class II | Active |
| TruForm+ | TFP005 | FDA UDI | Class II | Active |
| BellaFuse | D25.25D | FDA UDI | Class II | Active |
| TruForm | FG030 | FDA UDI | Class II | Active |
| BellaFuse | D1.1D | FDA UDI | Class II | Active |
| Mint | MINT 60WC1960 | FDA UDI | Class II | Active |
| BellaFuse | DBF24 | FDA UDI | Class II | Active |
| Mint | MINT 43BN1913 | FDA UDI | Class II | Active |
| Mint | MINT-I 14WC1985 | FDA UDI | Class II | Active |
| Mint | MINT-I 18WC1810 | FDA UDI | Class II | Active |
| TruForm | FP005 | FDA UDI | Class II | Active |
| C-Graft Putty | CG-P05 | 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.