Identity
- Trade Name
- JADE-32 EUDAMEDDRGEM FDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, analogue FDA UDI
- Device Name
- Mobile X-ray System EUDAMED100~240V~ 120kV FDA UDI
- Model / Reference
- JADE-32 EUDAMEDFDA UDIJADE-32, JADE-40 EUDAMED
- Description
- 100~240V~ 120kV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800011150082 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000111AM5000UM EUDAMED
- 510(k) Number
- K183388 FDA UDI
- FDA Product Code
- IZL FDA UDI
- EMDN Code
- Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMED
- GMDN Term
- Mobile basic diagnostic x-ray system, analogue FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1720 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Mobile basic diagnostic x-ray system, analogue
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
K183388 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 6b304e19-ece3-4cf7-a75b-d217bdbc3703 34 fields · synced Jul 24, 2026
- EUDAMED 5f124721-cd36-4c93-8fbc-580d2a61e046 61 fields · synced Jul 24, 2026