Identity
- Trade Name
- Grid-2100 EUDAMEDRadiographic Grid FDA UDI
- Generic Name
- Stationary x-ray grid FDA UDI
- Device Name
- Anti-Scatter Grid EUDAMEDA component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance. FDA UDI
- Model / Reference
- Grid-2100 EUDAMEDFDA UDIJSA-06-33 EUDAMED
- Description
- A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809413810211 EUDAMEDFDA UDI
- Basic UDI-DI
- 880941381Grid-2100DD EUDAMED
- 510(k) Number
- K945327 FDA UDI
- FDA Product Code
- IXJ FDA UDI
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Stationary x-ray grid FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1910 FDA UDI
- Market of Registration
- Italy 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
No
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
Grid-2100 by Jpi Healthcare. Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880941381Grid-2100DD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- JPI Healthcare Co., Ltd.
- EUDAMED SRN
- KR-MF-000002016
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED db2a25ca-728c-4e3c-b414-c3ce47f7d055 61 fields · synced Jun 18, 2026
- FDA UDI 48b641a6-344c-4229-8ea6-e710875df816 35 fields · synced May 30, 2026