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Sign in to claim this brandPATH medical GmbH
Germany·DE-MF-000006935
Last updated May 23, 2026
What PATH medical GmbH makes
PATH medical GmbH manufactures audiometric devices for hearing assessment, including evoked-potential audiometers, tone audiometers, and impedance audiometers. Their portfolio includes bone conduction audiometers (e.g., Bone conductor B71), diagnostic and screening systems (e.g., Sentiero Advanced, Sentiero Screening2), and accessories like ear probes and ear tips. Additional products include specialized cables (e.g., ALGO 7i ATA Cable long) and diagnostic sets (e.g., nanoAudio DD65v2 Set).
The company’s devices are classified under EU Medical Device Regulations as Class I, Class II, and Class IIa, with listings in the EU’s eudamed registry, as well as FDA submissions via 510(k) and UDI registries. PATH medical GmbH 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 PATH medical GmbH manufacture?
PATH medical GmbH specializes in audiometric devices used for hearing assessment. Their product range includes evoked-potential audiometers, tone audiometers, and impedance audiometers. Examples include bone conduction audiometers like the Bone conductor B71, diagnostic systems such as the Sentiero Advanced, and screening tools like the Sentiero Screening2. They also produce accessories like ear probes, ear tips, and specialized cables.
Where is PATH medical GmbH based?
PATH medical GmbH is based in Germany, as indicated by the country code 'DE'. The company’s headquarters and operations are located within Germany, which aligns with its regulatory submissions and device classifications under EU Medical Device Regulations.
Which regulatory registries list devices manufactured by PATH medical GmbH?
Devices from PATH medical GmbH are listed in the EU’s eudamed registry, which is the official database for medical devices under the EU Medical Device Regulations. Additionally, their devices appear in the FDA’s 510(k) and UDI registries, reflecting their presence in the US market. These listings help ensure compliance and traceability for their products.
How are devices from PATH medical GmbH classified under EU regulations?
PATH medical GmbH’s devices are classified under the EU Medical Device Regulations as Class I, Class II, and Class IIa. The classification depends on factors like the device’s intended use, risk level, and interaction with the patient. For example, simpler accessories like ear tips may fall under Class I, while more complex diagnostic systems like the Sentiero Desktop AuditData Tymp + OAE could be classified as Class II or IIa due to their role in critical assessments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Germany
- Address
- 65, Landsberger Straße, Germering, Germany
- Website
- www.pathme.de
- —
- —
- [email protected]
- Phone
- +49 89 80076502
- PRRC Contact
- Roland Sager
- EUDAMED SRN
- DE-MF-000006935
- FDA FEI Number
- —
- DUNS Number
- 551540334
Catalogue (310)
Page 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Headphone HDA 300 | 100630 | FDA UDI | Class II | Active |
| Insert Earphone PIEP | 100860-BL | FDA UDI | Class II | Active |
| Sentiero Advanced | 100340-US1 | FDA UDI | Class II | Active |
| Sentiero Diagnostic | 100250-US2 | FDA UDI | Class II | Active |
| Probe Tip 'small' PT-S 100pack | 100014-W-100 | FDA UDI | Class II | Active |
| 1077 Eartip 9-13 Foam 50 Pcs | 8-68-32808 | FDA UDI | Class II | Active |
| Bone Conductor B81 | 100888 | FDA UDI | Class II | Active |
| QScreen Set | 101275-T-D-A-EP | FDA UDI | Class II | Active |
| Ear Probe EP-VIP | 100539-US | FDA UDI | Class II | Active |
| QScreen Set | 101275-AS-HP | FDA UDI | Class II | Active |
| Sentiero Advanced | 100340-US3 | FDA UDI | Class II | Active |
| 1077, Ecc For Earhugs | 8-69-44600 | FDA UDI | Class II | Active |
| Sentiero Advanced | 100340-SC-A-LT | FDA UDI | Class II | Active |
| Sentiero Desktop Screening | 100497-US1 | FDA UDI | Class II | Active |
| Probe Tip 'Adult' PT-A 10pack | 100013-10 | FDA UDI | Class II | Active |
| Ear Tip ET-LT60M Pack/100 pcs. | 101368-100 | EUDAMEDFDA UDI | Class II | Active |
| Ear Tip ET-S03 Pack/50 pcs. | 100031-50 | FDA UDI | Class II | Unknown |
| nanoAudio Patient Response Button | 101420 | FDA UDI | Class II | Active |
| Ear Tip ET-S10 Pack/250 pcs. | 100032-250 | FDA UDI | Class II | Unknown |
| 1077 Eartip 8-11 Trans 250 Pcs | 8-68-32807 | FDA UDI | Class II | Unknown |
| Ear Tip ET-11 Pack/250 pcs. | 100125-250 | FDA UDI | Class II | Unknown |
| Bone Conductor B81 | 100909 | FDA UDI | Class II | Active |
| Sentiero Screening | 100250-US1 | FDA UDI | Class II | Active |
| Accessory box AB03 | 100261-BL | FDA UDI | Class II | Active |
| Senti Desktop | 100433 | FDA UDI | Class II | Active |
| Ear Tip ET-LT40G Pack/100 pcs. | 101365-100 | FDA UDI | Class II | Active |
| Electrode Trunk Cable | 100881 | FDA UDI | Class II | Active |
| AuDX Device with touchscreen | 100098-AU | FDA UDI | Class II | Active |
| QScreen Set | 101275-T-A-IP | FDA UDI | Class II | Active |
| Ear Tip ET-10 Pack/50 pcs. | 100064-50 | FDA UDI | Class II | Unknown |
| Senti Desktop Flex | 100470-SC | FDA UDI | Class II | Active |
| AuDX PRO Device with touchscreen | 100098-AUP | FDA UDI | Class II | Active |
| Insert Earphone otoInsert | 100273 | FDA UDI | Class II | Unknown |
| Label Printer Cable | 100199 | FDA UDI | Class II | Unknown |
| Sentiero Screening | 100250-US0 | FDA UDI | Class II | Active |
| Accessory Box Sentiero Ear Tips All Sizes for PT-A (Grason) | 100734 | FDA UDI | Class II | Unknown |
| Ear Tip ET-21 Pack/50 pcs. | 100577-50 | FDA UDI | Class II | Unknown |
| Sentiero Desktop Diagnostic | 100497-US7 | FDA UDI | Class II | Active |
| ALGO 7i Patient Cable Short | 101001 | FDA UDI | Class II | Active |
| Label Printer Cable | 100417 | FDA UDI | Class II | Unknown |
| Sentiero Screening2 | 100250-SC-D-LT | FDA UDI | Class II | Active |
| Accessory Box AB06 | 100902 | FDA UDI | Class II | Active |
| ABR / ASSR Lead Cable Set | 100891-2 | FDA UDI | Class II | Active |
| QScreen Set | 101275 | FDA UDI | Class II | Active |
| ABR / ASSR Lead Cable Set | 100891-1 | FDA UDI | Class II | Active |
| Ear Probe EP-LT (QScreen) | 101023 | FDA UDI | Class II | Active |
| Ear Tip ET-LT45G Pack/100 pcs. | 101366-100 | EUDAMEDFDA UDI | Class II | Active |
| Headphone PD-81 | 100118 | FDA UDI | Class II | Active |
| Sentiero Desktop Diagnostic | 100497-SK | FDA UDI | Class II | Active |
| Speech & Bone Kit Sentiero | 100780-B | FDA UDI | Class II | Active |
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