Angioway

FDA UDI

Class II (US FDA UDI)

by Lepu Medical Technology (Beijing) Co., Ltd.

Identity

Trade Name: Angioway FDA UDI
Generic Name: Catheter/overtube balloon inflator, single-use FDA UDI
Device Name: Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary angioplasty, PTCA; stent Implantation operation) provides the pressure inside the balloon. FDA UDI
Model / Reference: LP-P-30-YNP40 FDA UDI
Description: Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary angioplasty, PTCA; stent Implantation operation) provides the pressure inside the balloon. FDA UDI

Identifiers

Primary DI / UDI-DI: 06936733735961 FDA UDI
FDA Product Code: PTL FDA UDI
DTL FDA UDI
PTM FDA UDI
GMDN Term: Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1330 FDA UDI
870.4290 FDA UDI
870.1650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Catheter/overtube balloon inflator, single-use

Angioway by Lepu Medical Technology (Beijing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Lepu Medical Technology (Beijing) Co., Ltd.

Sources (1)

FDA UDI 6e7e447a-b308-4fcc-9daa-769ce1df1477 33 fields · synced May 30, 2026