Gongdong

FDA UDI

Class I (US FDA UDI)

by Zhejiang Gongdong Medical Technology Co., Ltd.,

Identity

Trade Name: Gongdong FDA UDI
Generic Name: Inoculating tool IVD, manual FDA UDI
Device Name: INDIVIDUALLY PACKAGED,10mL Virus Collection and Preservation System(VTM),G1029FN80 Swab,3mL VTM medium FDA UDI
Model / Reference: G1026V3 FDA UDI
Description: INDIVIDUALLY PACKAGED,10mL Virus Collection and Preservation System(VTM),G1029FN80 Swab,3mL VTM medium FDA UDI

Identifiers

Primary DI / UDI-DI: 06947462492476 FDA UDI
FDA Product Code: JSM FDA UDI
GMDN Term: Inoculating tool IVD, manual FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2390 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

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Inoculating tool IVD, manual

Gongdong by Zhejiang Gongdong Medical Technology Co., Ltd., — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Zhejiang Gongdong Medical Technology Co., Ltd.,

Sources (1)

FDA UDI 3021d577-9093-4dfa-987c-80e4de32c151 33 fields · synced May 31, 2026