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S_ite Amplienergyi25wrsrblk Blk
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21035426Model INSTANT FIT
by Wsaud A/S
Identity
- Trade Name
- S_ITE AMPLIENERGYI25WRSRBLK BLK EUDAMEDAMPLIFON FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- S_ITE AMPLIENERGYI25WRSRBLK BL FDA UDI
- Model / Reference
- INSTANT FIT EUDAMED21035426 EUDAMEDampli-energy I 2 5w RSTD FDA UDI
- Description
- S_ITE AMPLIENERGYI25WRSRBLK BL FDA UDI
Identifiers
- Catalog Number
- 21035426 FDA UDI
- Primary DI / UDI-DI
- 05714880224009 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-28-30-4J EUDAMED
- FDA Product Code
- OSM FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, in-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI874.3400 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
No
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
No
FDA UDI
S_ite Amplienergyi25wrsrblk Blk by Wsaud 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 | 5714880-WSA-28-30-4J | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (2)
- EUDAMED 1a089bc3-8024-4844-a846-89a896bb409c 61 fields · synced Jun 19, 2026
- FDA UDI 7d086ec1-dab2-452d-90a3-ae147453f0d6 35 fields · synced May 30, 2026