Ureteral Access Sheath
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Wellead Ureteral Access Sheath EUDAMEDUreteral Access Sheath FDA UDI
- Generic Name
- Ureteral introduction sheath FDA UDI
- Device Name
- Ureteral Access Sheath EUDAMED12Fr×13cm FDA UDI
- Model / Reference
- U03B011213 EUDAMEDFDA UDIUreteral Access Sheath EUDAMED
- Description
- 12Fr×13cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881134296 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FU03B01LP EUDAMED
- 510(k) Number
- K151084 FDA UDI
- FDA Product Code
- FED FDA UDI
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
- GMDN Term
- Ureteral introduction sheath FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Ureteral introduction sheath
Ureteral Access Sheath by Well Lead Medical Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral introduction sheath.
- Manawa Access Sheath — ENVASTE LTD · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Disposable Ureteral Guide Sheath — Dongguan ZSR Biomedical Technology Company Limited · Class IIa
- Disposable access sheath — Hangzhou Hawk Medical Technology Co., Ltd · Class IIa
- Sterile, Single Use Ureteral Access Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- Ureteral Access Sheath — Chengdu Daxan Innovative Medical Tech.Co.,Ltd · Class IIa
- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd · Class II
Cleared under the same submission
K151084 also covers:
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
- Ureteral Access Sheath — Well Lead Medical Co., Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (2)
- FDA UDI a4253e73-e748-437b-86b7-cc025e6bc310 34 fields · synced Jul 27, 2026
- EUDAMED 0bcfdaa3-6e61-4893-9aba-57df2c0982eb 61 fields · synced Jul 27, 2026