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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 3 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sentiero Desktop | 100434-SB | FDA UDI | Class II | Active |
| Sentiero Advanced | 100340-SK | FDA UDI | Class II | Active |
| Sentiero Basic AuDX Set | 100250-BL1 | FDA UDI | Class II | Unknown |
| Sentiero AuDX PRO | 8-04-16520 | FDA UDI | Class II | Active |
| Ear Tip ET-14 Pack/100 pcs. | 100230-100 | FDA UDI | Class II | Active |
| nanoTymp | 100948 | EUDAMEDFDA UDI | Class II | Active |
| Ear Tip ET-13 Pack/50 pcs. | 100144-50 | FDA UDI | Class II | Unknown |
| QScreen Set | 101275-D-A-EP | FDA UDI | Class II | Active |
| Ear Tip ET-13 Pack/250 pcs. | 100144-250 | FDA UDI | Class II | Unknown |
| Sentiero Advanced | 100340-SC-A | FDA UDI | Class II | Active |
| Senti Set 1 | 100330 | FDA UDI | Class II | Unknown |
| 1077 Eartip 5mm Blue 250 Pcs | 8-68-32801 | FDA UDI | Class II | Unknown |
| nanoTymp Set | 100948-SET | FDA UDI | Class II | Active |
| Ear Tip ET-12 Pack/100 pcs. | 100126-100 | FDA UDI | Class II | Active |
| Ear Tip PM009 Pack/100 pcs. | 100767-P-100 | FDA UDI | Class II | Active |
| Sentiero Desktop | 100434-DG | FDA UDI | Class II | Active |
| QScreen Set | 101275-D-A-ECC | FDA UDI | Class II | Active |
| Ear Tip PM007H Pack/100 pcs. | 100765-PH-100 | EUDAMEDFDA UDI | Class II | Active |
| 1077 Eartip 9-13 Foam 250 Pcs | 8-68-32809 | FDA UDI | Class II | Unknown |
| Ear Tip PM016 Pack/100 pcs. (Grason) | 100773-100 | FDA UDI | Class II | Unknown |
| QScreen Set | 101275-AS-ECC | FDA UDI | Class II | Active |
| Ear Tip ET-14 Pack/50 pcs. | 100230-50 | FDA UDI | Class II | Unknown |
| AuDX PRO FLEX Device with touchscreen | 100434-AUPF | FDA UDI | Class II | Active |
| Probe Tip 'small' PT-S 5pack | 100014-W-5 | FDA UDI | Class II | Unknown |
| Ear Tip ET-10 Pack/250 pcs. | 100064-250 | FDA UDI | Class II | Unknown |
| QScreen Set | 101275-A-IP | FDA UDI | Class II | Active |
| Ear Tip PM011 Pack/100 pcs. | 100769-P-100 | FDA UDI | Class II | Active |
| 1077 Abr Electrode Cable | 8-71-88400 | FDA UDI | Class II | Active |
| Ear Tip PM012 Pack/100 pcs. (Grason) | 100770-100 | FDA UDI | Class II | Unknown |
| Sentiero Desktop AuDX PRO Flex Set | 100497-BLP1 | FDA UDI | Class II | Unknown |
| nanoAudio DD65v2 Set with Patient Response Button | 101470-05 | FDA UDI | Class II | Active |
| Sentiero AuDX | 8-04-16510 | FDA UDI | Class II | Active |
| Bone Conductor B71W | 100214 | FDA UDI | Class II | Active |
| Headphone DD-45 | 100306 | FDA UDI | Class II | Active |
| QScreen Set | 101275-AS-IP | FDA UDI | Class II | Active |
| Ty-Ma | 100947 | FDA UDI | Class II | Active |
| Ear Tip ET-15 Pack/50 pcs. | 100699-50 | FDA UDI | Class II | Unknown |
| Ear Tip PM014 Pack/100 pcs. (Grason) | 100772-100 | FDA UDI | Class II | Unknown |
| Ear Tip PM006 Pack/100 pcs. (Grason) | 100764-100 | FDA UDI | Class II | Unknown |
| nanoAudio DD45 Set with Patient Response Button | 101470-02 | FDA UDI | Class II | Active |
| Ear Coupler Set | 100890-5 | FDA UDI | Class II | Active |
| Ear Tip Soft ET-17 Pack/50 pcs. | 100839-50 | FDA UDI | Class II | Unknown |
| QScreen Set | 101275-T-A-ECC | FDA UDI | Class II | Active |
| Headphone DD-65 | 100804 | FDA UDI | Class II | Active |
| Ear Probe EP-DP | 100530-US | FDA UDI | Class II | Active |
| Insert Earphone PIEP monaural | 100867 | FDA UDI | Class II | Active |
| Insert Earphone IP30 | 100832 | FDA UDI | Class II | Unknown |
| Sentiero Screening2 | 100250-SC-T | FDA UDI | Class II | Active |
| Accessory Box AB05 | 100676 | FDA UDI | Class II | Active |
| Sentiero Screening2 | 100250-SC-D | FDA UDI | Class II | Active |
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