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Set Pure C&G Bct Cros Ix Fgd
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 21044353Model RIC
by Wsaud A/S
Identity
- Trade Name
- SET PURE C&G BCT CROS IX FGD EUDAMEDSignia FDA UDI
- Generic Name
- Contralateral hearing unit FDA UDI
- Device Name
- SET PURE C&G BCT CROS IX FGD FDA UDI
- Model / Reference
- RIC EUDAMED21044353 EUDAMEDCROS Pure C&G BCT IX FDA UDI
- Description
- SET PURE C&G BCT CROS IX FGD FDA UDI
Identifiers
- Catalog Number
- 21044353 FDA UDI
- Primary DI / UDI-DI
- 05714880265354 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 Fgd 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 f00f2a69-0aeb-4641-a805-31c412739238 61 fields · synced Jul 15, 2026
- FDA UDI 692f4fed-dcb2-4504-a2a0-dd5556087722 35 fields · synced May 30, 2026