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Sign in to claim this brandRichard Wolf GmbH
Germany·DE-MF-000007048
Last updated September 17, 2026
What Richard Wolf GmbH makes
Richard Wolf GmbH manufactures reusable endoscopic electrosurgical handpieces and electrodes, including monopolar and bipolar designs, as well as rigid endoscopic forceps and telescopes. Their portfolio includes sheath tubes for Kerrison punches and reusable orthopaedic burs. They also produce modular electrosurgical systems like the ERAGON MODULAR and specialized devices such as the VERTEBRIS and ARTHROLUTION for surgical applications.
The company’s products are classified under EU Medical Device Regulations as Class I and Class II, with listings in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in Germany.
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 Richard Wolf GmbH primarily manufacture?
Richard Wolf GmbH specializes in reusable endoscopic electrosurgical tools, including monopolar and bipolar handpieces and electrodes. Their portfolio also covers rigid endoscopic forceps, telescopes, obturators, and sheath tubes—such as those for Kerrison punches—alongside reusable orthopaedic burs. They also develop modular electrosurgical systems like the ERAGON MODULAR and specialized devices such as the VERTEBRIS and ARTHROLUTION, all designed for surgical applications.
Where is Richard Wolf GmbH based, and how does that affect its regulatory standing?
Richard Wolf GmbH is headquartered in Germany, which means its devices comply with the European Union’s Medical Device Regulations (MDR). The company’s products are classified under EU MDR as either Class I or Class II, reflecting varying levels of risk and regulatory oversight. This classification determines how devices are authorized, with Class II requiring additional scrutiny, such as clinical evaluations or conformity assessments.
Which regulatory databases list Richard Wolf GmbH’s medical devices?
Richard Wolf GmbH’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. Additionally, their products appear in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance tracking in both the European and U.S. markets. These listings help healthcare providers and regulators verify device details and authorization status.
How are Richard Wolf GmbH’s devices classified under EU regulations, and why does this matter?
Richard Wolf GmbH’s devices fall under Class I (lower-risk items like some endoscopic sheaths or forceps) and Class II (moderate-risk items like electrosurgical handpieces or specialized surgical tools). Classification matters because it dictates the authorization process: Class II devices require additional evidence, such as clinical performance data or third-party audits, to demonstrate safety and effectiveness before they can be placed on the market. This ensures higher-risk devices meet stringent regulatory standards.
Are Richard Wolf GmbH’s devices reusable or single-use, and how does this impact their regulatory classification?
Richard Wolf GmbH manufactures both reusable devices (e.g., endoscopic handpieces, forceps, and orthopaedic burs) and single-use items (e.g., some bipolar electrosurgical electrodes). Reusability influences classification because reusable devices often require additional validation for sterilization processes and long-term durability, which can elevate their risk profile—though in this case, most reusable items remain Class I or II. Single-use devices, while exempt from sterilization concerns, are still assessed based on their surgical purpose and potential risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 32, Pforzheimer Str. , Knittlingen, Germany
- Website
- www.richard-wolf.com
- —
- —
- [email protected]
- Phone
- +497043350
- PRRC Contact
- —
- EUDAMED SRN
- DE-MF-000007048
- FDA FEI Number
- 3002808001
- DUNS Number
- 315304071
Catalogue (1777)
Page 13 of 36| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| E-Line | 8708534 | FDA UDI | Class II | Active |
| E-Line | 841603 | FDA UDI | Class II | Active |
| E-Line | 86520345 | FDA UDI | Class II | Unknown |
| Shark | 46792435 | FDA UDI | Class II | Active |
| S-Line | 8680225 | FDA UDI | Class II | Active |
| Moduline | 83941844 | FDA UDI | Class II | Unknown |
| E-Line | 841103 | FDA UDI | Class II | Unknown |
| Eragon Modular | 8395214 | FDA UDI | Class I | Active |
| E-Line | 8652284 | FDA UDI | Class II | Unknown |
| E-Line | 8702518 | FDA UDI | Class II | Active |
| Vertebris | 15208260 | FDA UDI | Class I | Unknown |
| E-Line | 8703517 | FDA UDI | Class II | Active |
| E-Line | 86860147 | FDA UDI | Class II | Active |
| Eragon Modular | 83961877 | FDA UDI | Class I | Active |
| E-Line | 8412042 | FDA UDI | Class II | Unknown |
| Greenlight | 8632225 | FDA UDI | Class II | Unknown |
| Panoview Plus | 8912402 | FDA UDI | Class II | Unknown |
| E-Line | 865411 | FDA UDI | Class II | Unknown |
| Eragon Modular Mini | 8391221 | FDA UDI | Class II | Active |
| Eragon Modular | 83931937 | FDA UDI | Class II | Active |
| Eragon Modular | 8393220 | FDA UDI | Class II | Active |
| E-Line | 8422235 | FDA UDI | Class II | Unknown |
| Shark/S-Line | 8622131 | FDA UDI | Class II | Unknown |
| Keyport | 885021 | FDA UDI | Class II | Unknown |
| Morce Power | 2307102 | FDA UDI | Class II | Unknown |
| Duorotate | 83993011 | FDA UDI | Class II | Unknown |
| Eragon Modular Mini | 8390220 | FDA UDI | Class II | Active |
| Endocam | 5514751 | FDA UDI | Class II | Unknown |
| E-Line | 868891 | FDA UDI | Class II | Active |
| Panoview Plus | 89344424 | FDA UDI | Class II | Unknown |
| Panoview Plus | 8933433 | FDA UDI | Class II | Active |
| Arthrolution | 891221235 | FDA UDI | Class I | Active |
| Eragon Modular | 83931867 | FDA UDI | Class II | Active |
| Shark | 46792635 | FDA UDI | Class II | Active |
| E-Line | 86500345S01 | FDA UDI | Class II | Active |
| Eragon Modular | 8394198 | FDA UDI | Class II | Active |
| Vertebris | 15208261 | FDA UDI | Class I | Unknown |
| E-Line | 86500347 | FDA UDI | Class II | Active |
| Princess | 865318 | FDA UDI | Class II | Active |
| Texas | 825101400 | FDA UDI | Class II | Unknown |
| E-Line | 86720447 | FDA UDI | Class II | Active |
| Arthrolution | 891211263 | FDA UDI | Class I | Active |
| Arthrolution | 891234077 | FDA UDI | Class I | Active |
| E-Line | 8667161 | FDA UDI | Class II | Active |
| Panoview Plus Hd | 892108253 | FDA UDI | Class II | Unknown |
| Inline | 8399311 | FDA UDI | Class II | Unknown |
| E-Line | 865467 | FDA UDI | Class II | Active |
| Eragon Bipolar | 839300362 | FDA UDI | Class II | Unknown |
| Eragon Modular | 8397654 | FDA UDI | Class I | Active |
| Panoview | 8860453 | FDA UDI | Class II | Active |
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