stents
CN → US| HS编码 | 关税税率 | 原产国 | 目的国 | 文档 |
|---|---|---|---|---|
| 9021100050 | 10.0% | CN | US | 官方文档 |
| 9021390000 | 10.0% | CN | US | 官方文档 |
| 7326908688 | 87.9% | CN | US | 官方文档 |
| 7326190080 | 87.9% | CN | US | 官方文档 |
| 9021100090 | 10.0% | CN | US | 官方文档 |
| 9021908100 | 10.0% | CN | US | 官方文档 |
商品图片
AI分析
🏥 Stents (Medical Implants & Vascular Devices)
🌐 HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Analysis | Professional Compliance Strategy
📌 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.
⚠️ Critical Distinction:
- If the product is marketed, labeled, and used as a medical implant (compensating for a defect/disability) → HS 9021.
- If the product is a raw material or industrial filter (no medical claim) → HS 7326.
- Note: Most trade inquiries for "stents" refer to medical devices. The tax implications differ drastically.
📦 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) | ✅ 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) | ✅ Medical |
9021.10.00.90 |
Orthopedic or fracture appliances... Other | Non-standard orthopedic supports, braces, splints | ✅ Medical |
9021.90.81.00 |
Orthopedic appliances... Other | Spare parts for orthopedic devices, non-implantable accessories | ✅ Medical |
7326.90.86.88 |
Other articles of iron or steel: Other: Other | Industrial stainless steel mesh, filters, reinforcement bars | ❌ Industrial |
7326.19.00.80 |
Other articles of iron or steel: Forged or stamped... Other | Industrial stamped metal parts, non-medical hardware | ❌ Industrial |
🔍 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.
💰 III. 2026 Latest Tariff Rate Details (Including Surtaxes & Policy Add-ons)
✅ Applicable Country: USA (US)
✅ Origin: China (CN)
✅ Effective Date: 2025/2026 (Current Trade Policy)
🎯 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 × 0% = $0 |
| De Minimis Eligible | ✅ 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 → FOOTNOTE:00 (Exempt from 301/IEEPA) |
📌 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.
🎯 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 × 77.9% |
| De Minimis Eligible | ❌ No (High tariff triggers entry formalities) |
| Legal Basis Path | USITC:7326.90.86.88 → FOOTNOTE:301(7326) → FOOTNOTE:STEEL(50%) |
📌 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.
🛠️ IV. Customs Clearance Practical Advice (Pitfall Avoidance Guide)
✅ 1. Documentation Checklist (Non-Negotiable)
| Document | Required? | Notes |
|---|---|---|
| ✅ FDA Establishment Registration | ✔️ | Must be registered with FDA for medical device import. |
| ✅ Product Description (Precise) | ✔️ | Use terms like "Coronary Stent," "Orthopedic Bone Plate," NOT "Metal Mesh." |
| ✅ Intended Use Statement | ✔️ | Clearly state: "Implanted in human body to treat vascular occlusion." |
| ✅ Material Composition | ✔️ | Specify alloy (e.g., Nitinol, Stainless Steel 316L), coating (Paclitaxel, etc.). |
| ✅ CE Mark / FDA 510(k) Clearance | ✔️ | Proof of regulatory approval in US/EU. |
| ✅ Commercial Invoice | ✔️ | Must match HS Code classification exactly. |
| ✅ Packing List | ✔️ | Include sterile packaging details if applicable. |
✅ 2. Classification Strategy (Key Mantra)
🔥 “Medical Claim = Ch90 (0% Tax) | Industrial Use = Ch73 (77.9% Tax)!”
| 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. |
✅ 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. |
🌍 V. Global Market Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff | Certification | Notes |
|---|---|---|---|---|
| 🇺🇸 USA | 9021.39.00.00 |
0% | FDA 510(k) + Registration | Exempt from 301/IEEPA |
| 🇪🇺 EU | 9021.39.00 |
0% (CE Mark) | CE MDR | Generally duty-free under EU-China agreements or GSP |
| 🇨🇳 China | 9021.39.00 |
0% | NMPA | Zero duty for medical devices |
| 🇯🇵 Japan | 9021.39.00 |
0% - 6% | PMDA | Varies by specific device type |
| 🇦🇺 Australia | 9021.39.00 |
0% | TGA | AUP (Free Trade Agreement) benefits |
📌 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.
📌 VI. Common Errors & Pitfall Guide (Lessons Learned)
❌ Error 1: Declaring "Coronary Stent" as "Steel Wire Mesh" (7326)
👉 Consequence: 77.9% Tax + FDA Rejection + Product Seizure.
❌ Error 2: Using generic term "Medical Implant" without specifying type
👉 Consequence: Customs inspection delay, potential re-classification to general hardware (higher tax).
❌ Error 3: Ignoring FDA Registration Number on Packaging
👉 Consequence: CBP (Customs and Border Protection) may hold shipment until FDA is contacted, causing port storage fees.
❌ Error 4: Mixing Stents with Surgical Instruments (different HS codes)
👉 Consequence: Complex classification; may trigger additional duties for non-exempt parts.
✅ Correct Approach:
“Coronary Drug-Eluting Stent, Nitinol, 3.0mm x 18mm, Sterile, Single Use, FDA Cleared, Model XYZ”
🎯 VII. Conclusion: Precision Classification Saves Millions
🎯 Remember the Mantra:
🔹 “Medical Implant = 9021 (0% Tax) | Industrial Mesh = 7326 (77.9% Tax)”
🔹 “Classify by Intended Use, Not Just Material”
🔹 “FDA Registration is as Important as HS Code”
📌 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.
📣 Immediate Action:
📞 Consult Regulatory Affairs + Verify FDA Status + Confirm HS Code with Customs Broker
🚀 Ensure Smooth Clearance, Zero Surprises, and Maximized Profit Margins!
✨ Professional Clearance Starts with Accurate Classification!
💼 Your Medical Products Deserve the 0% Duty Rate!
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关于 HS 编码归类
协调制度（HS）是由世界海关组织（WCO）制定的国际贸易商品分类标准。全球 200 多个国家采用 HS 系统作为海关关税、贸易统计和进出口监管的基础。
每个 HS 编码遵循以下层级结构：
- 章（2 位）——商品大类（例如：第 84 章：机器和机械设备）
- 品目（4 位）——章内的更具体分类
- 子目（6 位）——国际通用细分，所有 WCO 成员国统一使用
- 本国细分（8-10 位）——各国自行扩展的细分编码，如美国 HTSUS 10 位编码
正确的 HS 编码归类对于顺利通关、准确缴纳关税和遵守贸易法规至关重要。错误归类可能导致海关延误、多缴关税或罚款。
从CN进口到US时，适用的关税税率可能包括：
- 最惠国（MFN）税率——适用于 WTO 成员国的标准关税税率
- 普通税率——适用于无贸易协定国家
- 贸易救济关税——附加关税，如 301 条款（反倾销）、232 条款（国家安全）或反补贴税
本页内容仅供参考。如需正式归类，请咨询当地海关或持牌报关代理。