Custom Product Label Case for a Medical Device Company
Client Requirements
Client Background and Application Scenario
A medical-device company produces multiple medical consumables and small devices.
Each product requires a dedicated product identification label.
Products are sold to hospitals at all levels domestically and to overseas markets.
The client wants labels with unified visual identity and compliant legibility.
Client Requirements and Issues with the Original Solution
The client had previously run into several core issues with label procurement.
First, label compliance requirements were complex. Different SKUs involved UDI coding and batch-traceability requirements.
The original labels could only carry model information, and could not satisfy traceability-system needs.
Second, multi-SKU visual style was inconsistent. The original solution split labels into multiple versions per SKU.
Different suppliers delivered them, with large differences in hue and layout.
Third, small-batch flexible production was difficult. Of the 5 SKUs, 3 had first-batch quantities of 500-1,000 labels.
Traditional offset plate-making costs accounted for too high a share.
Core requirements: compliant legibility, unified visual identity, small-batch flexible production.
Project challenges:
✓ Large field differences across the 5 SKUs
✓ UDI coding and batch-traceability fields complete
✓ Unified multi-SKU visual style
Solution
Solution Overview
Provided the client with a medical-device product label solution.
Covering 5 SKUs, total 8,000 labels.
Face material uses 70μ synthetic paper with acrylic-series adhesive.
The process uses four-color printing plus PANTONE spot color.
Lamination uses 25μ matte film.
Material Selection Analysis
Why 70μ synthetic paper?
Synthetic-paper face material has good weather resistance.
In medical-device storage and transport scenarios, synthetic paper is more durable than coated paper.
Why not coated paper?
Coated paper tends to lift at edges in humid environments.
Medical-device storage cycles are long, so synthetic paper is more stable.
Why not PET face material?
PET would be over-spec for this scenario.
Medical-device labels do not need chemical-cleaning resistance.
Why acrylic-series adhesive?
Acrylic-series adhesive has good adhesion to common substrates (PE, PP, PET, paperboard).
Medical-device labels need long-term adhesion, and acrylic-series adhesive has more stable holding power.
Why PANTONE spot color?
PANTONE spot color ensures accurate reproduction of brand colors.
Medical-device labels involve brand standard colors, and inter-batch color-difference control is demanding.
Production Implementation and Quality Control
① Unified layout specifications across the 5 SKU artwork files
② PANTONE code calibration and verification
③ Four-color printing plus PANTONE spot color for each SKU label
④ 25μ matte film lamination
⑤ Die-cutting forming (including waste stripping)
⑥ Sampling inspection (appearance, conformability, print color difference, UDI QR-code readability)
⑦ Sorted by SKU, roll-packed and shipped
Results
Project Results
Delivery Data
✓ Products delivered: 5 SKUs of medical-device product identification labels
✓ Face material specification: 70μ synthetic paper
✓ Adhesive: acrylic-series adhesive
✓ Printing process: four-color printing plus PANTONE spot color
✓ Lamination: 25μ matte film
✓ Quantity delivered: 5 SKUs, total 8,000 labels
✓ Lead time: 5 working days
Usage Performance
✓ Unified visual style across the 5 SKUs; improved brand perception
✓ Stable UDI QR-code readability
✓ Small-batch production costs under control
Case Summary
For multi-SKU medical-device product identification needs, 70μ synthetic paper plus acrylic-series adhesive
plus PANTONE spot color is generally more durable and stable than coated paper.
This case delivered 5 SKUs, 8,000 labels in total, for a medical-device company.
Unified multi-SKU visual style.
LeXiang Packaging Experience
Applicable scenarios: medical-device product identification. Multi-SKU medical-consumable series identification. Medical products requiring small-batch flexible production.
Material recommendations: regular medical-device labels — first choice is 70μ synthetic paper plus acrylic-series adhesive. Humid environments or long-term storage — recommend matte film lamination. Multi-SKU — digital printing is the first choice.
Non-applicable scenarios: room-temperature short-cycle storage (coated paper is sufficient). Extra-large same-spec orders (traditional offset is more economical).
Notes: UDI symbology selection and data declaration are the registrant's responsibility. The printer outputs label artwork, variable data printing, and sample scanning per the client's finalized file. Medical-device marking legibility and durability must meet applicable regulatory requirements.
Why Choose LeXiang Packaging
✓ 5 SKUs, 8,000 medical-device product labels delivered within 5 working days
✓ PANTONE spot color calibrated against color cards; brand color difference ΔE≤2
✓ UDI QR codes measured by scanner at ≥99% readability
✓ Medical consumable markings reviewed for compliance against applicable regulations
Why Choose LeXiang Packaging
✓ 5 SKUs, 8,000 medical-device product labels delivered within 5 working days
✓ PANTONE spot color calibrated against color cards; brand color difference ΔE≤2
✓ UDI QR codes measured by scanner at ≥99% readability
✓ Medical consumable markings reviewed for compliance against applicable regulations
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Project Metrics
Project Overview
Industry: Healthcare (medical devices)
Product: Medical-device product identification labels
Quantity: 5 SKUs, 8,000 labels total
Material: 70μ synthetic paper plus acrylic-series adhesive
Process: Four-color printing plus PANTONE spot color, 25μ matte film lamination, die-cutting
Lead time: 5 working days (after artwork confirmation)
FAQ
What are the requirements for materials and inks on medical device labels?
Inks are typically required to comply with food-contact or medical-contact standards. A common reference is GB 4806.7. The specific required test reports should be confirmed by the client's regulatory team.
What is the minimum order quantity for medical device labels?
For digital proofing, orders can start from just a few dozen pieces. Mass production minimum is typically 500-1000 pieces. The specific quantity depends on materials and processes.
How long does proofing take for medical device labels?
Digital proofing usually takes 1-3 working days. Mass production takes 5-7 working days. The specific cycle depends on label specifications and process complexity.
Can medical device labels be laminated?
Yes. Matte film lamination enhances label durability, and the non-reflective matte finish facilitates barcode scanning at the terminal. Gloss film is rarely used in medical scenarios.
What compliance documents are needed for medical device labels?
Medical-contact test reports for inks and indirect food-contact certification for adhesives are typically required. The specific document list should be confirmed by the client's regulatory team.
Can coated paper be used for medical device labels?
Coated paper can be used for standard indoor warehousing. For humid environments or outdoor scenarios, synthetic paper is recommended. Synthetic paper offers superior weather resistance.
Can synthetic paper be used for medical device labels?
Yes. Synthetic paper face material has good weather resistance and is a common choice for medical device labels. 70μ synthetic paper with acrylic adhesive is a typical combination.
What is the typical lead time for medical device labels?
The proofing stage takes 3-5 working days. Mass production takes 5-7 working days. The specific cycle depends on specifications, quantity, and process complexity.
Do medical device labels need to be tamper-evident?
If they involve product sealing or tamper protection, one-time-use fragile paper or VOID materials are recommended. The specific choice should be confirmed by the client's regulatory team.
Can medical device labels use variable data printing?
Yes. Digital printing supports variable data, commonly used for production date, batch number, and expiration date identification. The UDI code format selection and data reporting are the responsibility of the registrant.
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