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Set Pure C&G Bct Cros Ix Sb
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21044357Model RIC
by Wsaud A/S
Identity
- Trade Name
- SET PURE C&G BCT CROS IX SB EUDAMEDSignia FDA UDI
- Generic Name
- Contralateral hearing unit FDA UDI
- Device Name
- SET PURE C&G BCT CROS IX SB FDA UDI
- Model / Reference
- RIC EUDAMED21044357 EUDAMEDCROS Pure C&G BCT IX FDA UDI
- Description
- SET PURE C&G BCT CROS IX SB FDA UDI
Identifiers
- Catalog Number
- 21044357 FDA UDI
- Primary DI / UDI-DI
- 05714880265316 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-29-15-52 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Contralateral hearing unit 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
Set Pure C&G Bct Cros Ix Sb 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-29-15-52 | 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 bd4135b4-4150-47ca-85d8-837aed07b310 61 fields · synced Jul 8, 2026
- FDA UDI 2d7313e7-e6c6-41f1-a5ab-ccdb65a2821c 35 fields · synced May 29, 2026