Identity
- Trade Name
- 1053 Freefit EUDAMEDGN Otometrics A/S FDA UDI
- Generic Name
- Hearing aid tester, electrical FDA UDI
- Device Name
- 1053 Charger for Freefit EUDAMED
- Model / Reference
- 8-62-39303 EUDAMED8-69-39210 EUDAMEDPMM RECD Probe Bin Short FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315001222 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA000875W EUDAMED
- FDA Product Code
- ETW FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Hearing aid tester, electrical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3310 FDA UDI
- Market of Registration
- Denmark 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
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
1053 Freefit by Natus Medical Denmark ApS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5713315NA000875W | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Denmark ApS
- EUDAMED SRN
- DK-MF-000001617
Sources (2)
- EUDAMED 3e81359f-22cb-4f0e-8c7a-5b25fbfcfc1c 61 fields · synced Jul 9, 2026
- FDA UDI c3167f01-7317-4f89-b1bf-36d1695ff681 32 fields · synced May 30, 2026