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Sign in to claim this brandEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság
Hungary·HU-MF-000003387
Last updated September 17, 2026
What EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság makes
The company manufactures single-use automatic cranial perforators designed for neurosurgical procedures, including models with Hudson ends for specific cranial applications. These devices are intended for controlled bone perforation during surgical interventions, ensuring precision and reducing manual effort.
The portfolio includes Class II and Class IIa devices, regulated under EU MDR and FDA UDI requirements, with listings in the EUDAMED and FDA UDI databases. The company operates from Hungary and complies with relevant European and American 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 EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság primarily manufacture?
EMD manufactures single-use automatic cranial perforators, specifically designed for neurosurgical procedures. These devices are intended to perform controlled bone perforation during surgery, reducing manual effort and improving precision. The portfolio includes models such as the NeuroLine series, some of which feature Hudson ends for specialized cranial applications.
Where is EMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság based?
The company is based in Hungary (HU), operating as a manufacturer and distributor of its medical devices from that location. Its regulatory compliance and device listings reflect adherence to both European and American medical device frameworks.
Which regulatory databases list EMD’s devices?
EMD’s devices are listed in the EUDAMED database under the EU Medical Device Regulation (MDR) framework and in the FDA’s Unique Device Identifier (UDI) database for compliance with U.S. requirements. These listings ensure traceability and regulatory transparency for its automatic cranial perforators.
How are EMD’s devices classified under medical device regulations?
EMD’s devices fall into Class II and Class IIa classifications, which are determined based on their intended use, risk level, and potential impact on patient safety. Class IIa devices pose a lower risk compared to Class II, but both require stringent regulatory oversight to ensure performance, safety, and compliance with manufacturing standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Hungary
- Address
- 113/B, Bartók Béla, Debrecen, Hungary
- Website
- www.emd.hu/en
- —
- —
- [email protected]
- Phone
- +36302703564
- PRRC Contact
- Gergő Ujvari
- EUDAMED SRN
- HU-MF-000003387
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Standard handpiece, L170 S, Straight | NSH-416 | EUDAMED | Class IIb | Active |
| Standard irrigation adapter, L95 | NSI-644 | EUDAMED | Class IIb | Active |
| NeuroLine | NLO-7/11-1.5 | FDA UDI | Class II | Active |
| NeuroLine | NLO-6/9-1.5 | FDA UDI | Class II | Active |
| NeuroLine | NLO-7/11-3.0 | FDA UDI | Class II | Active |
| NeuroLine | NLO-11/14-1.5 | FDA UDI | Class II | Active |
| NeuroLine | NLO-9/13-1.5 | FDA UDI | Class II | Active |
| NeuroLine | NLO-6/9-3.0 | FDA UDI | Class II | Active |
| NeuroLine Disposable Cranial Perforator with Hudson End | NLO-11/14-3.0 | EUDAMEDFDA UDI | Class IIa | Active |
| NeuroLine Disposable Cranial Perforator with Hudson End | NLO-9/13-3.0 | EUDAMEDFDA UDI | Class IIa | Active |
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