Identity
- Trade Name
- HONSUN FDA UDI
- Generic Name
- Mechanical external stethoscope FDA UDI
- Model / Reference
- HS-30J FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16970384250227 FDA UDI
- 510(k) Number
- K092245 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- GMDN Term
- Mechanical external stethoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mechanical external stethoscope
Honsun by Honsun (nantong) Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical external stethoscope.
- Sklar® — Sklar Corporation · Class I
- Adscope® — American Diagnostic Corporation · Class I
- Stethoscope — Rashman Corp. · Class I
- Greater Goods — Greater Goods, LLC · Class I
- Stethoscope — Rashman Corp. · Class I
- 3M™ Littmann® Classic III™ — 3M COMPANY · Class I
- Proscope™ — American Diagnostic Corporation · Class I
- Adscope® — American Diagnostic Corporation · Class I
Cleared under the same submission
K092245 also covers:
- Blood Pressure Kit — Dynarex Corp.
- LABTRON — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LUMISCOPE — GF Health Products, Inc
- LabTron — GF Health Products, Inc
- LabTron — GF Health Products, Inc
- LabTron — GF Health Products, Inc
- LabTron — GF Health Products, Inc
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
- Honsun (nantong) Co., Ltd
Sources (1)
- FDA UDI 8cc16a45-9b17-4a67-a484-252132e4307a 33 fields · synced Jun 1, 2026