Identity
- Trade Name
- Newsound FDA UDI
- Generic Name
- Audiometer testing system FDA UDI
- Model / Reference
- CH22 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945936702977 FDA UDI
- FDA Product Code
- MDL FDA UDI
- GMDN Term
- Audiometer testing system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Audiometer testing system
Newsound by Xiamen New Sound Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometer testing system.
- Newsound — Xiamen New Sound Technology Co., Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Xiamen New Sound Technology Co., Ltd.
Sources (1)
- FDA UDI 0e0699e0-92fc-4e08-90ae-81c8fd21fba0 32 fields · synced Jun 6, 2026