Drgem
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- GXR-68SD EUDAMEDDRGEM FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Digital diagnostic X-ray System EUDAMED380V3~ / 150kV FDA UDI
- Model / Reference
- GXR-68SD EUDAMEDFDA UDIGXR-32SD, GXR-40SD, GXR-52SD, GXR-68SD, GXR-82SD, GXR-C32SD, GXR-C40SD, GXR-C52SD, GXR-U32SD, GXR-U40SD EUDAMED
- Description
- 380V3~ / 150kV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800011140861 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000111DSGSD4000PB EUDAMED
- 510(k) Number
- K192364 FDA UDI
- FDA Product Code
- MQB FDA UDIKPR FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital 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, digital
Drgem by DRGEM Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 421d0c5e-35a5-4923-a6c9-97ad37b44a99 34 fields · synced Jun 19, 2026
- EUDAMED 85086348-e104-425a-bd4c-3bb963b8fe97 61 fields · synced Jun 19, 2026