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Drgem

FDA UDI

Class II (US FDA UDI)

by DRGEM Corporation

Identity

Trade Name
DRGEM FDA UDI
Generic Name
Stationary basic diagnostic x-ray system, analogue FDA UDI
Device Name
220-230V~ / 150kV FDA UDI
Model / Reference
SGXR-C52S FDA UDI
Description
220-230V~ / 150kV FDA UDI

Identifiers

Primary DI / UDI-DI
08800011121181 FDA UDI
510(k) Number
K192364 FDA UDI
FDA Product Code
KPR FDA UDI
GMDN Term
Stationary basic diagnostic x-ray system, analogue FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1680 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Stationary basic diagnostic x-ray system, analogue

Drgem by DRGEM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary basic diagnostic x-ray system, analogue.

Cleared under the same submission

K192364 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRGEM Corporation

Sources (1)

  • FDA UDI e15148bf-a82a-44e4-8780-6e920854f7b0 34 fields · synced Jun 1, 2026