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Chongjen

FDA UDI

Class I (US FDA UDI)

by Shanghai Chongjen Industry Co., Ltd.

Identity

Trade Name
Chongjen FDA UDI
Generic Name
Assistive coat FDA UDI
Model / Reference
Lab Coat,XXXXL FDA UDI

Identifiers

Primary DI / UDI-DI
06974681690536 FDA UDI
FDA Product Code
OEA FDA UDI
GMDN Term
Assistive coat FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Assistive coat

Chongjen by Shanghai Chongjen Industry Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assistive coat.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shanghai Chongjen Industry Co., Ltd.

Sources (1)

  • FDA UDI 747cfd8c-490c-42c8-8d19-c7fe90b71c36 32 fields · synced Jun 6, 2026