stents
CN β US| HS Code | Tariff Rate | Origin | Destination | Doc |
|---|---|---|---|---|
| 9021100050 | 10.0% | CN | US | Official Doc |
| 9021390000 | 10.0% | CN | US | Official Doc |
| 7326908688 | 87.9% | CN | US | Official Doc |
| 7326190080 | 87.9% | CN | US | Official Doc |
| 9021100090 | 10.0% | CN | US | Official Doc |
| 9021908100 | 10.0% | CN | US | Official Doc |
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AI Analysis
π₯ Stents (Medical Implants & Vascular Devices)
π HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Analysis | Professional Compliance Strategy
π I. Product Definition & Classification: What Exactly is a "Stent"?
Stents are tubular mesh devices used to keep hollow or tubular structures in the body open. In international trade, they are strictly regulated as medical devices and implants. Unlike general hardware, stents fall under specific health-related chapters due to their implantable nature.
Categorization Breakdown: 1. Orthopedic/Structural Support Stents: If the stent is used for structural support of bones or joints (rare, but possible in specific trauma contexts), it may fall under Chapter 90. 2. Vascular/Biliary/Stomach Stents: Most common medical stents (coronary, peripheral, esophageal) are considered "articles worn or carried, or implanted in the body to compensate for a defect or disability." These generally fall under HS 9021. 3. Metal Articles (Non-Medical Use) If a stainless steel mesh tube is used for industrial filtration or reinforcement (not medical), it falls under Chapter 73.
β οΈ Critical Distinction:
- If the product is marketed, labeled, and used as a medical implant (compensating for a defect/disability) β HS 9021.
- If the product is a raw material or industrial filter (no medical claim) β HS 7326.
- Note: Most trade inquiries for "stents" refer to medical devices. The tax implications differ drastically.
π¦ II. HS Code Classification Matrix (2026 Latest Tariff Authority)
| HS Code | Product Description | Applicable Scenario | Medical vs. Industrial |
|---|---|---|---|
9021.10.00.50 |
Orthopedic or fracture appliances; Parts and accessories thereof: Bone plates, screws, nails, and other internal fixation devices | Trauma surgery implants (plates, screws, intramedullary nails) | β Medical |
9021.39.00.00 |
Orthopedic appliances... Other: Other artificial parts of the body | Artificial joints, heart valves, vascular stents (if classified as artificial part) | β Medical |
9021.10.00.90 |
Orthopedic or fracture appliances... Other | Non-standard orthopedic supports, braces, splints | β Medical |
9021.90.81.00 |
Orthopedic appliances... Other | Spare parts for orthopedic devices, non-implantable accessories | β Medical |
7326.90.86.88 |
Other articles of iron or steel: Other: Other | Industrial stainless steel mesh, filters, reinforcement bars | β Industrial |
7326.19.00.80 |
Other articles of iron or steel: Forged or stamped... Other | Industrial stamped metal parts, non-medical hardware | β Industrial |
π Key Insight:
- Medical Stents (Vascular/Biliary) are typically classified under 9021.39.00.00 ("Other artificial parts of the body") or 9021.90.81.00 depending on specific FDA/CE classification and country rules.
- Orthopedic Implants (Bone plates/screws) are explicitly 9021.10.00.50.
- Industrial Steel Mesh (often confused with stent materials) is 7326.90.86.88.
π° III. 2026 Latest Tariff Rate Details (Including Surtaxes & Policy Add-ons)
β Applicable Country: USA (US)
β Origin: China (CN)
β Effective Date: 2025/2026 (Current Trade Policy)
π― 1. 9021.10.00.50 / 9021.39.00.00 / 9021.10.00.90 / 9021.90.81.00
(Medical/Orthopedic Implants & Appliances)
| Item | Detail |
|---|---|
| Base Tariff Rate | 0.0% (ad valorem) |
| Section 301 Surtax | 0.0% |
| IEEPA Surtax | 0.0% |
| Total Tax Rate | 0.0% |
| Tax Calculation | CIF Value Γ 0% = $0 |
| De Minimis Eligible | β Yes (Under $800, often exempt from entry formalities if low value, but medical devices still require FDA registration) |
| Legal Basis Path | USITC:9021.10.00.50 β FOOTNOTE:00 (Exempt from 301/IEEPA) |
π Explanation:
- Medical devices classified under Heading 9021 (Orthopedic appliances, artificial parts, hearing aids, etc.) are exempt from Section 301 tariffs and IEEPA surtaxes.
- This is a significant cost advantage for medical imports compared to general hardware.
- Why? The US policy prioritizes affordable access to medical treatments and implants.
π― 2. 7326.90.86.88 / 7326.19.00.80
(Industrial Steel Articles / Non-Medical Metal Parts)
| Item | Detail |
|---|---|
| Base Tariff Rate | 2.9% (ad valorem) |
| Section 301 Surtax | +25.0% |
| Steel/Aluminum/Copper Surtax | +50.0% (Specific to steel articles under certain conditions) |
| Total Tax Rate | 77.9% |
| Tax Calculation | CIF Value Γ 77.9% |
| De Minimis Eligible | β No (High tariff triggers entry formalities) |
| Legal Basis Path | USITC:7326.90.86.88 β FOOTNOTE:301(7326) β FOOTNOTE:STEEL(50%) |
π Explanation:
- If a "stent" is misclassified as industrial steel wire mesh or forged steel parts, it triggers massive tariffs.
- Steel Articles Surcharge: Specific to steel products, adding 50% on top of Section 301.
- Total 77.9% makes importing industrial steel parts from China extremely expensive.
π οΈ IV. Customs Clearance Practical Advice (Pitfall Avoidance Guide)
β 1. Documentation Checklist (Non-Negotiable)
| Document | Required? | Notes |
|---|---|---|
| β FDA Establishment Registration | βοΈ | Must be registered with FDA for medical device import. |
| β Product Description (Precise) | βοΈ | Use terms like "Coronary Stent," "Orthopedic Bone Plate," NOT "Metal Mesh." |
| β Intended Use Statement | βοΈ | Clearly state: "Implanted in human body to treat vascular occlusion." |
| β Material Composition | βοΈ | Specify alloy (e.g., Nitinol, Stainless Steel 316L), coating (Paclitaxel, etc.). |
| β CE Mark / FDA 510(k) Clearance | βοΈ | Proof of regulatory approval in US/EU. |
| β Commercial Invoice | βοΈ | Must match HS Code classification exactly. |
| β Packing List | βοΈ | Include sterile packaging details if applicable. |
β 2. Classification Strategy (Key Mantra)
π₯ βMedical Claim = Ch90 (0% Tax) | Industrial Use = Ch73 (77.9% Tax)!β
| Scenario | Correct HS Code | Tax | Risk if Misclassified |
|---|---|---|---|
| Vascular Stent (Implantable) | 9021.39.00.00 |
0% | If declared as 7326, risk of 77.9% penalty + seizure. |
| Orthopedic Bone Plate | 9021.10.00.50 |
0% | If declared as 7326, risk of 77.9% penalty. |
| Industrial Steel Filter Mesh | 7326.90.86.88 |
77.9% | If declared as 9021, risk of fraud charge + retroactive tax. |
| Stent Delivery Catheter | 9021.90.81.00 |
0% | Often bundled with stent; ensure correct pairing. |
β 3. Special Cases & Warnings
| Case | Handling Advice |
|---|---|
| Stents with Drug Coating | Still classified under 9021 (as the drug is part of the medical device function). Do not classify as pharmaceuticals (Ch30). |
| OEM/ODM Stents | Provide original equipment manufacturer agreements to prove brand/origin. |
| Sterile vs. Non-Sterile | Sterile stents may require additional FDA 510(k) clearance. Non-sterile may need sterilization documentation. |
| Samples for Clinical Trials | Can be imported under FDA Investigational New Drug (IND) exemption, but still requires proper HS classification (usually 9021) and bonded warehouse entry. |
π V. Global Market Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff | Certification | Notes |
|---|---|---|---|---|
| πΊπΈ USA | 9021.39.00.00 |
0% | FDA 510(k) + Registration | Exempt from 301/IEEPA |
| πͺπΊ EU | 9021.39.00 |
0% (CE Mark) | CE MDR | Generally duty-free under EU-China agreements or GSP |
| π¨π³ China | 9021.39.00 |
0% | NMPA | Zero duty for medical devices |
| π―π΅ Japan | 9021.39.00 |
0% - 6% | PMDA | Varies by specific device type |
| π¦πΊ Australia | 9021.39.00 |
0% | TGA | AUP (Free Trade Agreement) benefits |
π Conclusion:
- USA offers 0% duty for medical stents, making it a favorable market despite strict FDA regulations.
- Misclassification as industrial steel leads to 77.9% penalty, which is financially catastrophic.
- Always prioritize medical classification if the product is intended for human implantation.
π VI. Common Errors & Pitfall Guide (Lessons Learned)
β Error 1: Declaring "Coronary Stent" as "Steel Wire Mesh" (7326)
π Consequence: 77.9% Tax + FDA Rejection + Product Seizure.
β Error 2: Using generic term "Medical Implant" without specifying type
π Consequence: Customs inspection delay, potential re-classification to general hardware (higher tax).
β Error 3: Ignoring FDA Registration Number on Packaging
π Consequence: CBP (Customs and Border Protection) may hold shipment until FDA is contacted, causing port storage fees.
β Error 4: Mixing Stents with Surgical Instruments (different HS codes)
π Consequence: Complex classification; may trigger additional duties for non-exempt parts.
β Correct Approach:
βCoronary Drug-Eluting Stent, Nitinol, 3.0mm x 18mm, Sterile, Single Use, FDA Cleared, Model XYZβ
π― VII. Conclusion: Precision Classification Saves Millions
π― Remember the Mantra:
πΉ βMedical Implant = 9021 (0% Tax) | Industrial Mesh = 7326 (77.9% Tax)β
πΉ βClassify by Intended Use, Not Just Materialβ
πΉ βFDA Registration is as Important as HS Codeβ
π Pro Tip:
- For high-value stent shipments, apply for an Advance Ruling from CBP to confirm HS Code.
- Ensure Product Labeling matches the declared HS Code description (e.g., do not label as "Filter" if declared as "Stent").
- Keep Clinical Evidence ready to prove medical use if challenged.
π£ Immediate Action:
π Consult Regulatory Affairs + Verify FDA Status + Confirm HS Code with Customs Broker
π Ensure Smooth Clearance, Zero Surprises, and Maximized Profit Margins!
β¨ Professional Clearance Starts with Accurate Classification!
πΌ Your Medical Products Deserve the 0% Duty Rate!
Customer Reviews
About HS Code Classification
The Harmonized System (HS) is an internationally standardized nomenclature developed by the World Customs Organization (WCO) to classify traded products. Over 200 countries use the HS system as the basis for customs tariffs, trade statistics, and import/export regulations.
Each HS code follows a hierarchical structure:
- Chapter (2 digits) β Broad category of goods (e.g., Chapter 84: Machinery and Mechanical Appliances)
- Heading (4 digits) β More specific grouping within the chapter
- Subheading (6 digits) β Internationally standardized breakdown, used by all WCO member countries
- National subdivisions (8-10 digits) β Country-specific extensions for further classification, such as US HTSUS 10-digit codes
Correct HS code classification is essential for smooth customs clearance, accurate duty payment, and compliance with trade regulations. Misclassification can lead to customs delays, overpayment of duties, or penalties.
When importing from CN to US, the applicable tariff rates may include:
- Most-Favored-Nation (MFN) rate β The standard duty rate applied to WTO members
- General rate β Applied to countries without trade agreements
- Trade remedy duties β Additional tariffs such as Section 301 (anti-dumping), Section 232 (national security), or countervailing duties
The information provided on this page is for reference purposes only. For official classification, please consult with your local customs authority or a licensed customs broker.