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Entomed SA204
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SA204Model SA 201, SA202, SA203, SA204
Identity
- Trade Name
- Entomed SA204 EUDAMEDEntomed By Auditdata FDA UDI
- Generic Name
- Audiometric/hearing aid tester FDA UDI
- Device Name
- Entomed SA201, SA202, SA203, SA204 EUDAMED
- Model / Reference
- SA 201, SA202, SA203, SA204 EUDAMEDSA204 EUDAMEDSA 204 (English) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05711781001258 EUDAMEDFDA UDI
- Basic UDI-DI
- 05711781DHF2009ZW EUDAMED
- Direct Marketing DI
- 05711781001258 EUDAMED
- FDA Product Code
- EWO FDA UDI
- EMDN Code
- Z121401 AUDIOMETERS EUDAMED
- GMDN Term
- Audiometric/hearing aid tester FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1050 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Entomed SA204 by Auditdata A/S — 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 | 05711781DHF2009ZW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Auditdata A/S
- EUDAMED SRN
- DK-MF-000011415
Sources (2)
- EUDAMED 149b6812-fddc-4c89-adf3-980962336c35 61 fields · synced Jun 19, 2026
- FDA UDI fe000879-5823-459e-b00d-920fc4382429 32 fields · synced May 29, 2026