Medical Laser Marking

Medical Laser Marking

UDI (Unique Device Identification) regulations require every medical device to have a traceable 2D code or text. Hayi Technology’s medical laser marking service uses UV or fiber lasers to make permanent marks on stainless steel, titanium, ceramic, and plastic. The mark has high contrast, no contamination, and meets FDA and MDR requirements.
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Product Introduction

Medical Devices Must Have a Permanent Unique Identifier

 

UDI (Unique Device Identification) regulations require every medical device to have a traceable 2D code or text. Hayi Technology's medical laser marking service uses UV or fiber lasers to make permanent marks on stainless steel, titanium, ceramic, and plastic. The mark has high contrast, no contamination, and meets FDA and MDR requirements. For example, an orthopedic implant company needed to mark UDI codes on titanium bone screws. The font size was only 0.5mm. We used a UV laser. The code was clear and readable under a microscope. The client passed the audit. This case shows laser marking is necessary for compliance. Our MOQ is 1 piece.

 

Parameter

Details

Minimum Order Qty

1 piece

Sample Time

1 day minimum

Batch Lead Time

~15 days

Laser Type

UV laser (355nm) – cold marking, minimal heat

Mark Content

Text, logo, Data Matrix 2D code, serial number

Materials

Stainless steel, titanium, aluminum, PEEK, PC, ABS

Mark Depth

0.01-0.05mm, permanent

Readability Verification

Grade A (per device)

Certification

ISO9001:2015 (Cert No. 19925Q02204R0S)

 

UV Cold Laser – No Damage to the Material

We use a UV laser (355nm) with minimal heat input. This is good for temperature sensitive materials. We can mark text, logos, Data Matrix 2D codes, and serial numbers. Materials include stainless steel, titanium, aluminum, PEEK, PC, and ABS. The mark depth is 0.01-0.05mm and is permanent. We hold ISO9001:2015 certification. Each product gets a code readability verification (Grade A). Before packing, we do 100% full inspection. We also accept third-party inspection. Our medical laser marking service is available for small batches.

3M6A0015

 

Small Batches Also Accepted, 1 Day Minimum

 

Medical device batches are often small but regulations are strict. Our custom sample time is 1 day minimum. Batch marking lead time is about 15 days. Payment: 30% deposit, balance before shipment. Trade terms: EXW, FOB, DDP. We send marking effect photos during production. If any problem occurs, we talk immediately and improve after we find the cause. We have a dedicated after-sales person. Compliance is a must for medical device makers. Our technicians can help you design the 2D code size and position. You can help your clients meet regulatory requirements.

 

Hot Tags: medical laser marking, China medical laser marking manufacturers

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