Identity
- Trade Name
- nanoTymp EUDAMEDFDA UDI
- Generic Name
- Impedance audiometer FDA UDI
- Device Name
- nanoTymp EUDAMEDTY-MU FDA UDI
- Model / Reference
- 100948 EUDAMEDFDA UDITU100948 EUDAMED
- Description
- TY-MU FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223143694 EUDAMEDFDA UDI
- Basic UDI-DI
- 0426022TY-MU-2aNP EUDAMED
- FDA Product Code
- PTP FDA UDI
- EMDN Code
- Z12149005 IMPEDANCE METERS FOR THE AUDITORY SYSTEM EUDAMED
- GMDN Term
- Impedance audiometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1090 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Impedance audiometer
nanoTymp by PATH medical GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (2)
- FDA UDI 2ea92ab4-d9e0-4d27-9cba-3d852ffd788d 33 fields · synced Jul 9, 2026
- EUDAMED 54b8b621-9679-4e33-80c2-7ca935a4bca6 61 fields · synced Jul 9, 2026