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Sign in to claim this brandRAZEK EQUIPAMENTOS LTDA
US
Last updated May 23, 2026
What RAZEK EQUIPAMENTOS LTDA makes
The company produces single-use orthopaedic burs designed for surgical procedures, as well as reusable orthopaedic surgical procedure kits that do not contain medications. These tools are intended for use in orthopaedic surgeries where precision cutting or preparation of bone is required.
The portfolio consists of Class I devices, which are generally considered to pose the lowest risk and are subject to minimal regulatory oversight. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. The manufacturer is based in 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 Razek Equipamentos Ltda manufacture?
Razek Equipamentos Ltda produces two primary types of orthopaedic devices: single-use orthopaedic burs, which are designed for precise cutting or bone preparation during surgery, and reusable orthopaedic surgical procedure kits that do not contain medications. These tools are specifically intended for orthopaedic procedures where controlled bone manipulation is required.
Where is Razek Equipamentos Ltda based?
Razek Equipamentos Ltda is based in the United States. The company’s location influences its regulatory compliance, particularly in relation to U.S. requirements for device classification and traceability.
How are Razek Equipamentos Ltda’s devices classified under U.S. regulations?
Razek Equipamentos Ltda’s devices fall under Class I classification, which is the lowest risk category for medical devices in the U.S. This classification applies to products like single-use burs and reusable orthopaedic kits that pose minimal risk to patients. Class I devices typically require less regulatory scrutiny, though they must still meet basic safety and performance standards.
Are Razek Equipamentos Ltda’s devices listed in any regulatory databases?
Yes, Razek Equipamentos Ltda’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and compliance by assigning a unique identifier to each device, helping track its distribution, usage, and regulatory status. This is particularly important for Class I devices, which must still adhere to labeling and manufacturing requirements.
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
- 898213154
Catalogue (11827)
Page 230 of 237| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Razek Equipamentos | 978390000 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738130710 | FDA UDI | Class I | Active |
| Razek Equipamentos | 978790300 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738210670 | FDA UDI | Class I | Active |
| Razek Equipamentos | 974930000 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738380780 | FDA UDI | Class I | Active |
| Razek Equipamentos | 732871400 | FDA UDI | Class I | Active |
| Razek Equipamentos | 730820001 | FDA UDI | Class I | Active |
| Razek Equipamentos | 730530011 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738640070 | FDA UDI | Class I | Active |
| Razek Equipamentos | 735900300 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738210590 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738741080 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738721480 | FDA UDI | Class I | Active |
| Razek Equipamentos | 490060270 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738390260 | FDA UDI | Class I | Active |
| Razek Equipamentos | 734820000 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738430470 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738700410 | FDA UDI | Class I | Active |
| Razek Equipamentos | 978880720 | FDA UDI | Class I | Active |
| Razek Equipamentos | 978580500 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738380270 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738360890 | FDA UDI | Class I | Active |
| Razek Equipamentos | 730040014 | FDA UDI | Class I | Active |
| Razek Equipamentos | 737110000 | FDA UDI | Class I | Active |
| Razek Equipamentos | 978880790 | FDA UDI | Class I | Active |
| Razek Equipamentos | 978560400 | FDA UDI | Class I | Active |
| Razek Equipamentos | 730030014 | FDA UDI | Class I | Active |
| Razek Equipamentos | 978870180 | FDA UDI | Class I | Active |
| Razek Equipamentos | 732660001 | FDA UDI | Class I | Active |
| Razek Equipamentos | 978751000 | FDA UDI | Class I | Active |
| Razek Equipamentos | 978791200 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738380340 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738700820 | FDA UDI | Class I | Active |
| Razek Equipamentos | 736861100 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738130310 | FDA UDI | Class I | Active |
| Razek Equipamentos | 736581700 | FDA UDI | Class I | Active |
| Razek Equipamentos | 978360400 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738710120 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738731510 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738710920 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738180570 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738711920 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738710140 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738210710 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738741090 | FDA UDI | Class I | Active |
| Razek Equipamentos | 736770300 | FDA UDI | Class I | Active |
| Razek Equipamentos | 734350000 | FDA UDI | Class I | Active |
| Razek Equipamentos | 738160210 | FDA UDI | Class I | Active |
| Razek Equipamentos | 979080080 | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Razek Equipamentos Ltda Sao Carlos Sao Paulo · BR FEI 3021907852