FDA device listing

Scan-Mate (Black),Scan-Mate (Blue),Scan-Mate MagaGen,TisssuePro Distal Sleeve, MN Retractor,TisssuePro Distal Sleeve, MN…

FDA device listing 1546981856 · Zhejiang Jasmine Oralcare Products Co., Ltd.

Key facts

Proprietary names Scan-Mate (Black),Scan-Mate (Blue),Scan-Mate MagaGen,TisssuePro Distal Sleeve, MN Retractor,TisssuePro Distal Sleeve, MN Retractor Single-Use,TisssuePro Proximal Sleeve, MN Retractor,TisssuePro Single Sleeve, MN Retractor
Owner/operator Zhejiang Jasmine Oralcare Products Co., Ltd.
Owner/operator number 10061424
Product codes EIF
Device names EIF - Accessories, Retractor, Dental
Device class Class I
Classification regulations (21 CFR) 872.4565
Review panels Dental
Registered establishments ZHEJIANG JASMINE ORALCARE PRODUCTS CO., LTD.
Establishment registrations 3015432501
FEI numbers 3015432501
Establishment operations Contract Manufacturer, Foreign Exporter, 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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