Identity
- Trade Name
- Single-Use Ureterorenoscope FDA UDI
- Generic Name
- Flexible video ureterorenoscope, single-use FDA UDI
- Model / Reference
- HU30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970462546474 FDA UDI
- 510(k) Number
- K240374 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Flexible video ureterorenoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible video ureterorenoscope, single-use
Single-Use Ureterorenoscope by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Flexible video ureterorenoscope, single-use.
- Ambu® aScope™ 5 Uretero — Ambu A/S · Class II
- REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
- Ambu® aScope™ 5 Uretero — Ambu A/S · Class II
- REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
- REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
- n.a, — Karl Storz GmbH & Co. KG · Class II
- REDPINE — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class II
- Single-Use Ureterorenoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
Cleared under the same submission
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
Sources (1)
- FDA UDI 35051a91-6963-42c8-9b28-2ec783a153e2 33 fields · synced Jun 8, 2026