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Kit Silk C&G 3ix Eu Blk Tr
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21026938Model INSTANT FIT
by Wsaud A/S
Identity
- Trade Name
- KIT SILK C&G 3IX EU BLK TR EUDAMEDSIGNIA FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- KIT SILK C&G 3IX EU BLK TR FDA UDI
- Model / Reference
- INSTANT FIT EUDAMED21026938 EUDAMEDKIT Silk C&G 3IX FDA UDI
- Description
- KIT SILK C&G 3IX EU BLK TR FDA UDI
Identifiers
- Catalog Number
- 21026938 FDA UDI
- Primary DI / UDI-DI
- 05714880210378 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-26-30-3U EUDAMED
- FDA Product Code
- OSM 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 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
Kit Silk C&G 3ix Eu Blk Tr 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-26-30-3U | 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 0df6ac94-10c0-4c1e-8819-2ae61d2b02c9 61 fields · synced Jul 16, 2026
- FDA UDI 251a2622-189e-4945-8cab-ef9304f99f90 35 fields · synced May 29, 2026