← Back to catalogue
1053 Freefit
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8-69-39207Model 8-62-35100Ref 8-04-11808Model 8-62-39303Ref 8-62-39400Ref 1053 Freefit
Identity
- Trade Name
- 1053 Freefit EUDAMEDGN Otometrics A/S FDA UDI
- Generic Name
- Hearing aid tester, electrical FDA UDI
- Device Name
- REM Test tubes, 1.1mm (50 pcs.) EUDAMED1053 Charger for Freefit EUDAMED
- Model / Reference
- 8-62-35100 EUDAMED8-69-39207 EUDAMED8-62-39303 EUDAMED8-04-11808 EUDAMED8-62-39400 EUDAMED1053 Freefit EUDAMEDAurical FreeFit, Complete Solution FDA UDIREM Tube, Blue Handle (50 pcs.) FDA UDIPMM RECD Probe Short FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713315001192 EUDAMEDFDA UDI05713315004100 EUDAMEDFDA UDI05713315004117 EUDAMEDFDA UDI05713315003318 EUDAMEDFDA UDI
- Basic UDI-DI
- 5713315NA000885Y EUDAMED5713315NA000875W EUDAMED
- FDA Product Code
- ETW FDA UDIEWO FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Hearing aid tester, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3310 FDA UDI874.1050 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 UDIFDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
1053 Freefit by Natus Medical Denmark ApS — Class I — 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 | 5713315NA000885Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (9)
- EUDAMED 779b0007-2b00-4062-8b5e-1a6cd07a0615 61 fields · synced Aug 4, 2026
- EUDAMED cde57181-177b-4916-8425-78e062a6b80c 61 fields · synced May 18, 2026
- FDA UDI 42066520-4049-45e4-b3a4-d5842e1f2662 32 fields · synced May 29, 2026
- FDA UDI ba14f61b-a824-4226-a469-606c52a4093d 32 fields · synced May 30, 2026
- FDA UDI bbd16c62-cc41-4aa0-bea2-63beaa2649a7 32 fields · synced May 30, 2026
- FDA UDI 737bdbfc-5953-47e3-8251-174e37b0db45 32 fields · synced May 30, 2026
- EUDAMED c1cd2619-efe9-4415-a504-d998dff484b1 61 fields · synced Jul 9, 2026
- EUDAMED 82ee9b67-fc94-4fac-826a-e06456070998 61 fields · synced Jul 9, 2026
- EUDAMED 12c198dd-7960-46be-9a0b-831888459ba8 61 fields · synced Aug 4, 2026