surgical gut suture for sewing
CN → US| HS编码 | 关税税率 | 原产国 | 目的国 | 文档 |
|---|---|---|---|---|
| 3006100100 | 10.0% | CN | US | 官方文档 |
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AI分析
🧵 Surgical Gut Suture for Sewing (Sterile Absorbable Suture)
🌐 HS Code Reference & Clearance Guide | 2026 Latest Tariff Analysis | Professional Customs Strategy
📌 I. Product Definition & Classification: What is "Surgical Gut Suture for Sewing"?
"Surgical Gut Suture" refers to sterile surgical catgut or similar sterile suture materials, typically made from natural collagen (sheep or cattle intestine) or synthetic absorbable polymers, used for ligating blood vessels and closing wounds in medical procedures.
Key Characteristics: - Material: Natural (gut) or synthetic (e.g., polyglactin 910, poliglecaprone 25). - State: Sterile, ready for surgical use. - Form: Thread/yarn, often with or without needles pre-attached. - Function: Absorbable wound closure; does not require removal.
⚠️ Critical Distinction:
- If the suture is sterile and intended for surgical wound closure, it falls under Chapter 3006.
- If it is non-sterile or intended for non-medical sewing (e.g., leather stitching), it may fall under different chapters (e.g., Chapter 54 or 63), but the query specifies "surgical," so we focus on 3006.10.01.00.
📦 II. HS Code Classification Details (2026 Latest Tariff Authority Mapping)
| HS Code | Product Description | Applicability | Sterile? | Surgical Use? |
|---|---|---|---|---|
3006.10.01.00 |
Pharmaceutical goods: Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure | Medical devices, surgical supplies | ✅ Yes | ✅ Yes |
🔍 Key Reminder:
- Must be sterile: Non-sterile sutures are classified differently (e.g., under Chapter 54 for textile yarns).
- Must be for surgical/dental use: Non-medical threads (e.g., embroidery floss, leather thread) are not covered here.
- Includes absorbable materials: Even if not traditional "gut," synthetic absorbable sutures (e.g., Vicryl, Monocryl) fall under this code if sterile and surgical.
💰 III. 2026 Latest Tariff Rate Details (Including Surcharges, Policy Add-ons)
✅ Applicable Country: United States (US)
✅ Country of Origin: China (CN)
✅ Effective Date: From November 10, 2025 (and subsequent imports)
🎯 1. 3006.10.01.00 —— Sterile Surgical Catgut & Similar Sterile Suture Materials
| Item | Content |
|---|---|
| Base Tariff Rate | 0.0% (ad valorem) |
| Additional Tariff (Section 301 / IEEPA) | 0.0% |
| Total Tariff Rate | 0.0% |
| Tax Calculation | CIF Value × 0.0% = $0 |
| De Minimis Eligibility | ❌ Not Applicable (Pharmaceutical/Medical Goods typically exempt from de minimis but subject to FDA/CFR regulations) |
| Legal Basis Path | Chapter 30, Note 4 → HS 3006.10.01.00 |
📌 Explanation:
- Base Tariff: 0% under US Harmonized Tariff Schedule for sterile surgical sutures.
- Additional Tariffs: No 301/IEEPA surcharges apply to this specific HS code (unlike electronics or steel).
- Total Rate: 0% – This is a tariff-free item under current US trade policy.
- Regulatory Note: While tariff-free, FDA approval (510(k) or PMA) and CFR Title 21 compliance are mandatory for importation.
🛠️ IV. Customs Clearance Practical Advice (Battle-Tested Pitfall Guide)
✅ 1. Required Documentation Checklist (All Mandatory)
| Document | Mandatory | Notes |
|---|---|---|
| ✅ FDA Establishment Registration | ✔️ | Importer must be registered with FDA |
| ✅ 510(k) Clearance or PMA Approval | ✔️ | Proof of medical device clearance for surgical sutures |
| ✅ Certificate of Sterility | ✔️ | Issued by certified lab (e.g., ISO 11135/11137 compliance) |
| ✅ Product Specification Sheet | ✔️ | Material, absorbability, strength, dimensions |
| ✅ Commercial Invoice | ✔️ | Clearly state "Sterile Surgical Suture, HS 3006.10.01.00" |
| ✅ Packing List | ✔️ | Detail sterile packaging integrity |
| ✅ Bill of Lading/Air Waybill | ✔️ | Standard shipping document |
| ✅ FDA Prior Notice | ✔️ | Must be filed before arrival (BDCS system) |
✅ 2. Declaration Tips (Key Mnemonic)
🔥 "Sterile + Surgical + Absorbable = 3006.10.01.00 | 0% Tariff, 100% Compliance!"
| Scenario | Correct Declaration | Incorrect Action |
|---|---|---|
| Sterile surgical catgut | 3006.10.01.00 |
Misclassify as "textile thread" → Higher tariff + FDA hold |
| Non-sterile suture for crafts | Not 3006.10.01.00 | Declare as surgical → FDA rejection |
| Sterile absorbable synthetic suture | 3006.10.01.00 |
Use wrong code → 5-10% tariff + penalties |
| Suture with pre-attached needle | 3006.10.01.00 |
Separate needle declaration → Complex, unnecessary |
✅ 3. Special Cases Handling
| Scenario | Handling Advice |
|---|---|
| FDA Inspection Hold | Ensure sterility certificates and 510(k) numbers are on invoice; delay may occur if docs missing |
| Lot Traceability | FDA requires lot numbers for recall tracking; include in declaration |
| Expiry Date | Sutures must have valid shelf life at time of import; expired goods rejected |
| Non-3006.10.01.00 Codes | If not sterile or not surgical, do not use this code; consult customs broker |
🌍 V. Global Market Clearance Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff | Certification Required | Notes |
|---|---|---|---|---|
| 🇺🇸 United States | 3006.10.01.00 |
0% | FDA 510(k)/PMA, Sterility Cert | Tariff-free, strict FDA |
| 🇨🇳 China | 3006.10.01.00 |
0% | NMPA Registration, Sterility | 0% import duty, domestic production common |
| 🇪🇺 European Union | 3006.10.10 |
0% | CE Mark (MDR), ISO 13485, Sterility | Free trade within EU, strict MDR compliance |
| 🇬🇧 United Kingdom | 3006.10.10 |
0% | UKCA Mark, Sterility | Post-Brexit, UKCA required |
| 🇯🇵 Japan | 3006.10.10 |
0% | PMDA Approval, Sterility | 0% tariff, stringent approval process |
📌 Conclusion:
- Global Consensus: Sterile surgical sutures are typically 0% tariff worldwide.
- Regulatory Hurdle: The main barrier is FDA/CE/NMPA approval, not tariffs.
- US Advantage: No additional 301/IEEPA surcharges make this item highly competitive for import into the US.
📌 VI. Common Errors & Pitfall Guide (Lessons Learned)
❌ Error 1: Declaring non-sterile sutures as sterile surgical
👉 Consequence: FDA rejection, return/destruction, fines.
❌ Error 2: Using wrong HS code (e.g., 5401 for textile thread)
👉 Consequence: 5-10% tariff applied + FDA hold for missing medical clearance.
❌ Error 3: Omitting sterility certificates
👉 Consequence: Customs detention, costly re-testing or destruction.
❌ Error 4: Not filing FDA Prior Notice
👉 Consequence: Cargo denied entry, shipment delayed indefinitely.
✅ Correct Practice:
"Sterile Surgical Absorbable Suture, Gut/Polyglactin, 0 Gauge, 45cm, Pack of 10, 510(k) Number K123456, Lot# ABC, Exp. 2027, FDA Prior Notice Filed, HS 3006.10.01.00"
🎯 VII. Conclusion: Precision Declaration, Risk-Free Clearance, Cost Savings!
🎯 Remember the Mnemonic:
🔹 "Sterile + Surgical = 3006.10.01.00 | 0% Tariff | 100% FDA Compliance!"
🔹 "Wrong Code = Wrong Tariff + FDA Rejection = Total Loss!"
📌 Pro Tip:
- Ensure FDA 510(k) clearance is obtained before shipping.
- File FDA Prior Notice via BDCS system at least 8 hours before arrival (vessel) or 4 hours (air).
- Keep sterility certificates and lot traceability records for at least 2 years post-expiry.
📣 Immediate Action Required:
📞 Engage a FDA-registered customs broker
📦 Prepare sterility certificates + 510(k) numbers
🚀 Achieve zero-tariff, hassle-free clearance into the US market!
✨ Professional Customs Clearance Starts with Accurate Classification!
💼 Your every cent saved is meticulously calculated!
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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。