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Ureteral Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref U06A070812Model Open Tapered Tip
Identity
- Trade Name
- Ureteral Catheter EUDAMEDFDA UDI
- Generic Name
- Ureteral catheter FDA UDI
- Device Name
- Ureteral Catheter EUDAMEDOpen Cone Tip6/10Fr FDA UDIOpen Tapered Tip8Fr FDA UDI
- Model / Reference
- U06A070812 EUDAMEDFDA UDIOpen Tapered Tip EUDAMEDU06A080212 FDA UDI
- Description
- Open Cone Tip6/10Fr FDA UDIOpen Tapered Tip8Fr FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881158322 EUDAMED06936881157387 FDA UDI06936881157257 FDA UDI
- Basic UDI-DI
- 69449327FU06A07MK EUDAMED
- 510(k) Number
- K220036 FDA UDI
- FDA Product Code
- KOD FDA UDI
- EMDN Code
- U020101 URETERAL CATHETERS WITH CYLINDRICAL TIP EUDAMED
- GMDN Term
- Ureteral catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ureteral catheter
Ureteral Catheter 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 catheter.
- Bard® Polyurethane Ureteral Catheters, Open Tip — C. R. Bard, Inc. · Class II
- Bard® Woven Ureteral Catheter — C. R. Bard, Inc. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Coloplast — Coloplast A/S · Class II
- UroForce® Balloon Dilation Catheter — C. R. Bard, Inc. · Class II
- Metal Catheter — RZ-Medizintechnik GmbH · Class I
- Bard® X-Force® Balloon Dilation Catheter — C. R. Bard, Inc. · Class II
- Porges Coloplast — Coloplast A/S · Class II
Cleared under the same submission
K220036 also covers:
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
- Ureteral Catheter — Well Lead Medical Co., Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 (3)
- FDA UDI 54147f4a-f77f-4210-b37f-c541bb15e1d6 34 fields · synced Aug 1, 2026
- FDA UDI 8bee8859-ecce-40af-9e15-6ab0afdeb45c 34 fields · synced May 30, 2026
- EUDAMED 75458300-7d90-45be-ade3-2a76410a6581 61 fields · synced Aug 1, 2026