Gr40cwd
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- GR40CWD EUDAMEDNA FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging conversion system FDA UDI
- Device Name
- Retrofit kit for digital radiography EUDAMEDThe GR40CW and GR40CWD Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. FDA UDI
- Model / Reference
- GR40CW, GR40CWD EUDAMEDGR40CWD EUDAMEDFDA UDI
- Description
- The GR40CW and GR40CWD Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806090171147 EUDAMEDFDA UDI
- Basic UDI-DI
- 8806090DGRGR001YN EUDAMED
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11031180 SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Diagnostic x-ray digital imaging conversion system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Germany 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
No
The GR40CWD device is a retrofit kit specifically designed for digital radiography, providing an integrated and reliable solution for various medical applications. By integrating advanced technology into a user-friendly package, this device offers superior performance, durability, and ease of use.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152094 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K153401 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K181631 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8806090DGRGR001YN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Samsung Electronics Co., Ltd
- EUDAMED SRN
- KR-MF-000020682
- Authorised Representative
- Samsung Electronics GmbH DE-AR-000007005
Sources (3)
- EUDAMED fc163376-e738-486e-8114-c3000a53b32a 61 fields · synced Jul 19, 2026
- FDA UDI d1b34d70-a03e-42b8-b10f-69276b4eefcc 33 fields · synced May 30, 2026
- FDA 510(k) K152094 1 fields · synced May 18, 2026