FDA device listing

Wristband S3, S5, S7, S8

FDA device listing 1468310449 · Shenzhen Xinzhengyu Technology Co.,Ltd.

Key facts

Proprietary names Wristband S3, S5, S7, S8
Owner/operator Shenzhen Xinzhengyu Technology Co.,Ltd.
Owner/operator number 10086862
Product codes FZZ
Device names FZZ - Marker, Skin
Device class Class I
Classification regulations (21 CFR) 878.4660
Review panels General & Plastic Surgery
Registered establishments SHENZHEN XINZHENGYU TECHNOLOGY CO.,LTD.
Establishment registrations 3026297283
FEI numbers 3026297283
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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