Rhyk Technologies GmbH
Germany DE-MF-000009068 Last updated 8 Jun 2026
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- Devices
- 4
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Rhyk NEO XL Ref RH0103
Rhyk NEO S Ref RH0100
Rhyk NEO M Ref RH0101
Rhyk NEO L Ref RH0102
EUDAMED certificates
SGS FIMKO OY 0598 1 certificate
- FI23/00000046 Withdrawn
Quality management system EU MDR
- Issued
- 19 Dec 2024
- Expires
- 26 Sep 2026
- Reason
- Failure contractual obligations
Related companies
Notified bodies
- SGS FIMKO OY 0598
What Rhyk Technologies GmbH makes
Rhyk Technologies GmbH manufactures a series of Rhyk NEO devices, including the NEO XL, NEO S, NEO M, and NEO L. These products are designed as surgical instruments for minimally invasive procedures, specifically for use in orthopaedic and spinal surgeries, including bone cutting and preparation.
The Rhyk NEO devices fall under EU Class IIa classification and are listed in the EUDAMED registry. The company is based in Germany and adheres to EU regulatory requirements for medical devices.
Frequently asked questions
What types of medical devices does Rhyk Technologies GmbH manufacture?
Rhyk Technologies GmbH manufactures a series of surgical instruments called Rhyk NEO devices, including the NEO XL, NEO S, NEO M, and NEO L. These devices are specifically designed for minimally invasive orthopaedic and spinal surgeries, such as bone cutting and preparation. They are intended to assist surgeons in precise and controlled procedures.
Where is Rhyk Technologies GmbH based?
Rhyk Technologies GmbH is based in Germany. The company operates within the European Union, which means its devices must comply with EU regulatory standards and requirements for medical devices.
Are Rhyk Technologies GmbH’s devices listed in any regulatory registries?
Yes, the Rhyk NEO devices are listed in the EUDAMED registry. EUDAMED is the European database for medical devices, where manufacturers provide information about their products to ensure transparency and traceability across the EU market.
How are Rhyk Technologies GmbH’s devices classified under EU regulations?
The Rhyk NEO devices fall under EU Class IIa classification. This classification is determined based on the risk associated with the device’s intended use. Class IIa devices are considered to have a medium risk and require compliance with specific EU regulatory requirements, including design controls, risk management, and clinical evaluation.
Information
- Country
- Germany
- Address
- 2d, Bundeskanzlerplatz, Bonn, Germany
- Website
- rhyk.com
- [email protected]
- PRRC contact
- Frank-Peter Tillmann
- EUDAMED SRN
- DE-MF-000009068