Identity
- Trade Name
- INT FDA UDI
- Generic Name
- Interventional radiology percutaneous-access kit, single-use FDA UDI
- Device Name
- Introducer Set EUDAMED
- Model / Reference
- CTR03 EUDAMEDFDA UDI4F, 5F, 6F, 7F, 8F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950900923548 EUDAMEDFDA UDI
- Basic UDI-DI
- 69509009CEIKRW EUDAMED
- 510(k) Number
- K180178 FDA UDI
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
- GMDN Term
- Interventional radiology percutaneous-access kit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 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
No
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: Interventional radiology percutaneous-access kit, single-use
Int by Shanghai Kindly Medical Instruments Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Interventional radiology percutaneous-access kit, single-use.
- Access Needle — Mermaid Medical A/S · Class I
- EXTesia — Curatia Medical Limited · Class IIa
- SWL-Pathfinder — SWL Medizin GmbH · Class III
- Mini Sheath — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- EXTesia — Curatia Medical Limited · Class IIa
- Introducer Set — Shanghai INT Medical Instruments Co., Ltd. · Class IIa
- EXTesia — Curatia Medical Limited · Class IIa
- Shun Guider — Shunmei Medical Co.,Ltd · Class IIa
Cleared under the same submission
K180178 also covers:
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INT — Shanghai Kindly Medical Instruments Co., Ltd.
- INTRODUCER SET — VALFLUX GROUP, LLC
- INTRODUCER SET — VALFLUX GROUP, LLC
- INTRODUCER SET — VALFLUX GROUP, LLC
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
- Shanghai Kindly Medical Instruments Co., Ltd.
Sources (2)
- FDA UDI e520b5d1-7fdf-4955-a1b0-09a932effe29 33 fields · synced Jun 18, 2026
- EUDAMED 048ced71-747d-4a22-9d46-33499fafa330 61 fields · synced Jun 18, 2026