2. DataMatrix Code Specifications for Medical Devices
Shenzhen, China
Published: 7 月 3, 2026
2. DataMatrix Code Specifications for Medical Devices
The 2D DataMatrix (ECC 200) is the standard AIDC format for medical device UDI marking.
Code Size and Cell Specifications
| Parameter | Standard Application | Small Instruments |
|---|---|---|
| Code size | 2.5–4.5 mm² | As small as 0.4 mm² |
| Cell size (x-dimension) | ~0.300 mm | ~0.200 mm |
| Quiet zone | Per ISO/IEC 16022 | Per ISO/IEC 16022 |
| Error correction | ECC 200 (Reed-Solomon) | ECC 200 (Reed-Solomon) |
| Quality grade | Per ISO/IEC 15415 | Per ISO/IEC 15415 |
Practical Sizing Examples
| Device | Mark Size | Mark Content | Marking Time |
|---|---|---|---|
| Surgical scissors (SS316) | 2.71×2.71mm | Logo + 2D DataMatrix | ~5 seconds |
| Bone screw (Ti, 1–2mm dia.) | ~0.4mm | Micro DataMatrix | — |
| Implant tray | 4.5×4.5mm | Full UDI + text | ~8 seconds |
| HDPE bottle | 2.71mm² | Logo + 2D DataMatrix | ~2 seconds |
