Drgem
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- GXR-C52S EUDAMEDDRGEM FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, analogue FDA UDI
- Device Name
- Diagnostic X-ray System EUDAMED220-230V~ / 125kV FDA UDI
- Model / Reference
- GXR-C52S EUDAMEDFDA UDIGXR-32S, GXR-40S, GXR-52S, GXR-68S, GXR-82S, GXR-C32S, GXR-C40S, GXR-C52S, GXR-U32S, GXR-U40S EUDAMED
- Description
- 220-230V~ / 125kV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800011120306 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000111ASGS20009P EUDAMED
- 510(k) Number
- K192364 FDA UDI
- FDA Product Code
- KPR FDA UDI
- EMDN Code
- Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, analogue FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary basic diagnostic x-ray system, analogue
Drgem by DRGEM Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stationary basic diagnostic x-ray system, analogue.
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- X-CEL X-RAY CORPORATION — ARQUILLA, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
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- X-CEL X-RAY CORPORATION — ARQUILLA, INC. · Class II
Cleared under the same submission
K192364 also covers:
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
- DRGEM — DRGEM Corporation
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DRGEM Corporation
Sources (2)
- FDA UDI 1db99392-9406-4c09-8ac7-5eebbaba90b3 34 fields · synced Aug 5, 2026
- EUDAMED 0a3f3cbf-3ddd-4718-ab7c-81fd25eb5f34 61 fields · synced Aug 5, 2026