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Sign in to claim this brandMorpheus AG
Germany·DE-MF-000012037
Last updated September 17, 2026
What Morpheus AG makes
Morpheus AG manufactures orthopaedic surgical tools, including reusable rongeurs for bone and tissue removal, such as the PHANTOM MULTI-BITE KERRISON RONGEUR, and single-use tissue debris collectors like the PHANTOM BONE COLLECTOR. Their portfolio also includes reusable cleaning utensils for surgical instruments and endoscopes, such as the PUSHER, as well as orthopaedic instruments like the OsteoPoint for joint and limb procedures.
The company’s devices are regulated under EU Class I and Class II/IIa classifications, with listings in the EUDAMED database, as well as FDA submissions via 510(k) and UDI registries. Morpheus AG is based in Germany and adheres to relevant European and US regulatory frameworks for medical devices.
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 Morpheus AG manufacture?
Morpheus AG specialises in orthopaedic surgical tools, primarily focused on reusable and single-use instruments. Their portfolio includes rongeurs like the PHANTOM MULTI-BITE KERRISON RONGEUR, designed for bone and tissue removal during orthopaedic procedures. They also produce tissue debris collectors, such as the PHANTOM BONE COLLECTOR (single-use), and reusable cleaning utensils like the PUSHER for surgical instruments and endoscopes. Additional devices include orthopaedic instruments like the OsteoPoint, which assist in joint and limb surgeries.
Where is Morpheus AG based, and how does this affect their regulatory compliance?
Morpheus AG is based in Germany, which places their devices under the regulatory oversight of the European Union’s Medical Device Regulations (MDR). Since they manufacture Class I, Class II, and Class IIa devices, their products are listed in the EUDAMED database—a centralised EU registry for medical devices. This ensures transparency and compliance with EU regulatory requirements, while also enabling global market access through additional registries like the FDA’s 510(k) and UDI systems in the US.
Which regulatory registries list Morpheus AG’s devices, and why are these important?
Morpheus AG’s devices are listed in the EUDAMED database (for EU compliance), as well as the FDA’s 510(k) and UDI registries (for US market authorisation). These registries are critical because they demonstrate that the devices meet the necessary safety, performance, and regulatory standards in their respective markets. EUDAMED ensures traceability under EU MDR, while FDA listings confirm compliance with US regulations, facilitating market access in both regions.
How are Morpheus AG’s devices classified under EU and US regulations?
Under EU regulations, Morpheus AG’s devices fall into Class I (low-risk), Class II (moderate-risk), and Class IIa (specific moderate-risk) categories. This classification determines the level of scrutiny and documentation required for market authorisation, such as clinical evaluations or conformity assessments. In the US, their devices are registered via the FDA’s 510(k) pathway (for Class II) or UDI (for all classes), ensuring compliance with US medical device regulations while maintaining consistency with global safety standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 18, Bahnhofstraße , Spaichingen, Germany
- Website
- morpheus.com.ag
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Timo Rack
- EUDAMED SRN
- DE-MF-000012037
- FDA FEI Number
- 3016450051
- DUNS Number
- 315142027
Catalogue (29)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OsteoPoint | HCT-03-160 | FDA UDI | Class II | Active |
| Pusher | KR-0200 | FDA UDI | Class I | Active |
| Phantom Multi-Bite Kerrison Rongeur | KR-2003 | FDA UDI | Class II | Active |
| Phantom Multi-Bite Kerrison Rongeur | KR-2503 | FDA UDI | Class II | Active |
| OsteoPoint | HCT-BC-16 | FDA UDI | Class II | Active |
| Phantom Multi-Bite Kerrison Rongeur | KR-2504 | FDA UDI | Class II | Active |
| OsteoPoint | HCT-04-200 | FDA UDI | Class II | Active |
| Phantom Multi-Bite Kerrison Rongeur | KR-2502 | FDA UDI | Class II | Active |
| Phantom Multi-Bite Kerrison Rongeur | KR-2002 | FDA UDI | Class II | Active |
| Phantom Bone Collector, Single-Use, Sterile | KR-0100 | FDA UDI | Class II | Active |
| Rebellion | REB-04-160 | FDA UDI | Class II | Active |
| Pusher | STO-015 | FDA UDI | Class I | Active |
| Rebellion | REB-02-160 | FDA UDI | Class II | Active |
| OsteoPoint | HCT-04-160 | FDA UDI | Class II | Active |
| Rebellion | REB-03-160 | FDA UDI | Class II | Active |
| OsteoPoint | HCT-03-200 | FDA UDI | Class II | Active |
| OsteoPoint | HCT-02-160 | FDA UDI | Class II | Active |
| Phantom Multi-Bite Kerrison Rongeur | KR-2004 | FDA UDI | Class II | Active |
| OsteoPoint | HCT-02-200 | FDA UDI | Class II | Active |
| Rebellion Gr3x200 mm | REB-03-200 | EUDAMEDFDA UDI | Class IIa | Active |
| Rebellion; Phantom Multi-Bite Kerrison Rongeur | K221818 | FDA 510(k) | Class II | Active |
| Rebellion, Phantom Multi-Bite Kerrison Rongeur | K230256 | FDA 510(k) | Class II | Active |
| Rebellion, Phantom Multi-Bite Kerrison Rongeur | K200768 | FDA 510(k) | Class II | Active |
| Rebellion Stanze | REB-02-200 | EUDAMEDFDA UDI | Class IIa | Active |
| Rebellion Gr2x250 mm | REB-02-250 | EUDAMEDFDA UDI | Class IIa | Active |
| Rebellion Gr3x250 mm | REB-03-250 | EUDAMEDFDA UDI | Class IIa | Active |
| Rebellion Gr4x200 mm | REB-04-200 | EUDAMEDFDA UDI | Class IIa | Active |
| Rebellion Gr4x250 mm | REB-04-250 | EUDAMEDFDA UDI | Class IIa | Active |
| Knochen- und Gewebefalle | BC-16 | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Morpheus Co., Ltd. Yongin Gyeonggi · KR FEI 3043542875