Identity
- Trade Name
- VAN PRO 201 EUDAMEDNewsound FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- hearing aids EUDAMED
- Model / Reference
- BTE EUDAMED06945936701710 EUDAMEDVan Pro 201 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945936701710 EUDAMEDFDA UDI
- Basic UDI-DI
- 69459367xs001G3 EUDAMED
- FDA Product Code
- ESD FDA UDI
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
Yes
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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Air-conduction hearing aid, behind-the-ear
Van Pro 201 by Xiamen NewSound Technology Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, behind-the-ear.
- Oticon — Oticon A/S · Class II
- Amplifon — Sonova AG · Class II
- Phonak Naída L30-SP — Sonova AG · Class II
- Phonak — Phonak, Inc. · Class II
- GN ReSound — Gn Hearing A/S · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
- HHM — Oticon A/S · Class II
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 | 69459367xs001G3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Xiamen NewSound Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000041673
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 0519f72c-f7be-4ecb-aac2-03b92fdfef9d 61 fields · synced Jun 19, 2026
- FDA UDI 232d03c4-7be4-4347-8f0a-d41e0c97e579 32 fields · synced May 30, 2026