FDA device listing

Balloon Inflators

FDA device listing 1734121811 · Jiangsu Vedkang Medical Science and Technology Co.,Ltd

Key facts

Proprietary names Balloon Inflators
Owner/operator Jiangsu Vedkang Medical Science and Technology Co.,Ltd
Owner/operator number 10053440
Product codes PTM
Device names PTM - Syringe, Balloon Inflation, Exempt
Device class Class II
Classification regulations (21 CFR) 870.1650
Review panels Cardiovascular
Registered establishments Jiangsu Vedkang Medical Science and Technology Co.,Ltd.
Establishment registrations 3013526170
FEI numbers 3013526170
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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