Gut Hemostatic Material
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AI分析
🩸 Gut Hemostatic Material (Hemostats)
🌐 HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Analysis | Professional Level Customs Strategy
📌 I. Product Definition and Classification: What Exactly is "Gut Hemostatic Material"?
Gut Hemostatic Material typically refers to surgical devices made from chromicized catgut (collagen derived from sheep or cattle intestine) or synthetic absorbable sutures used to tie off blood vessels (ligature) and achieve hemostasis (stop bleeding) during surgery.
In international trade, these are strictly regulated medical supplies. The classification depends heavily on whether they are absorbable sutures (for internal tissue) or non-absorbable, and whether they are prepared for retail sale (e.g., in sterile packs with needles).
Key Distinction:
- Absorbable Sutures (Catgut/Chromic Gut): Used for internal tissues that heal naturally. These fall under Chapter 30 (Pharmaceuticals) or Chapter 90 (Medical Instruments), depending on specific preparation.
- Non-Absorbable/Other Materials: May fall under different headings if not considered "pharmaceutical preparations."
⚠️ Critical Classification Point:
- If the product is chromic catgut suture (absorbable), it is generally classified under 3006.99 or 9018.39.
- If it is a surgical instrument (forceps, clamps) used to apply hemostasis (not the material itself), it falls under 9018.90.
- Note: The prompt specifies "Gut Hemostatic Material," which strongly implies absorbable sutures made of catgut.
📦 II. HS Code Classification Details (2026 Latest Tariff Authority Comparison)
| HS Code | Product Description | Applicable Scenario | Absorbable? |
|---|---|---|---|
3006.99.50.00 |
Surgical dressings and other articles for medical, surgical, dental or veterinary purposes (incl. catgut, collagen, etc.) | Chromic Catgut Sutures, absorbable ligatures, sterile surgical packs | ✅ Yes |
9018.39.00.00 |
Syringes, needles, catheters and similar apparatus (incl. suture needles) | Suture needles with attached absorbable/non-absorbable threads | ✅/❌ No |
3004.90.99.00 |
Medicaments consisting of mixed or unmixed products | If marketed as a "hemostatic agent" (powder/foam) rather than suture | ✅ Yes |
9018.90.90.00 |
Other instruments and appliances used in medical, surgical, dental or veterinary sciences | Hemostats (clamps/forceps) – NOT the material | ❌ No (Instrument) |
6307.90.98.90 |
Other made-up articles (non-medical) | Non-sterile, non-medical grade gut strings (rare) | N/A |
🔍 Key Reminder:
- Most "Gut Hemostatic Materials" (Catgut Sutures) fall under3006.99.50.00. This is because catgut is considered a surgical dressing/preparation derived from animal intestine.
- Do NOT classify as9018unless it is a needle with attached thread. The material itself (the gut string) is 3006.
- Ensure the product is sterile. Non-sterile catgut may face stricter regulatory hurdles or different classifications.
💰 III. 2026 Latest Tariff Rate Details (Including Surtaxes, Policy Surcharges)
✅ Applicable Country: United States (US)
✅ Country of Origin: China (CN)
✅ Effective Date: November 10, 2025 onwards (for subsequent imports)
🎯 1. 3006.99.50.00 – Surgical Dressings and Other Articles for Medical Use (Catgut Sutures)
| Item | Content |
|---|---|
| Base Tax Rate | 0% (ad valorem) |
| USITC Surtax | +25% (Under USITC Footnote 9903.88.01) |
| IEEPA Surtax | +10% (Against China/HK products, effective Nov 10, 2025) |
| Total Tax Rate | 45% |
| Tax Calculation | CIF Value × 45% |
| De Minimis Eligibility | ❌ Not Eligible (deny_de_minimis) |
| Legal Basis Path | IEEPA:9903.01.25 → IEEPA:9903.01.24 → USITC:3006.99.50.00 → FOOTNOTE:9903.88.01 |
📌 Explanation:
- "USITC Surtax 25%": Comes from Section 301 of the Trade Act, targeting specific Chinese medical supplies.
- "IEEPA 10%": Additional tariff under the International Emergency Economic Powers Act.
- Total 45% is a very high tariff. This applies to catgut sutures, collagen hemostats, and similar absorbable surgical materials.
🎯 2. 9018.39.00.00 – Suture Needles with Attached Threads (If Applicable)
| Item | Content |
|---|---|
| Base Tax Rate | 0% |
| USITC Surtax | +25% |
| IEEPA Surtax | +10% |
| Total Tax Rate | 45% |
| Tax Calculation | CIF × 45% |
| De Minimis Eligibility | ❌ Not Eligible |
| Legal Basis Path | IEEPA:9901.25 → IEEPA:9903.01.24 → USITC:9018.39.00.00 → FOOTNOTE:9903.88.01 |
📌 Note:
- If your "Gut Hemostatic Material" includes needles (pre-mounted sutures), it is classified here.
- Even if the thread is absorbable, the presence of the needle can shift classification to 9018, but the tariff rate remains 45% for Chinese origin.
🛠️ IV. Customs Clearance Practical Advice (Battle-Tested Pitfall Guide)
✅ 1. Required Documentation Checklist (All Are Mandatory)
| Document | Must Provide | Explanation |
|---|---|---|
| ✅ Product Specification Sheet | ✔️ | Must specify material (Catgut/Chromic Catgut), absorbability, sterile status, dimensions. |
| ✅ Sterilization Certificate | ✔️ | Proof of Ethylene Oxide (EtO) or Gamma sterilization. Critical for Chapter 30. |
| ✅ FDA Establishment Registration & Device Listing | ✔️ | Must be FDA-registered. Non-listed devices will be detained. |
| ✅ Commercial Invoice | ✔️ | Clear description: "Sterile Chromic Catgut Sutures, Surgical Hemostatic Material, HS 3006.99.50.00" |
| ✅ Country of Origin Certificate | ✔️ | To confirm Chinese origin (for tariff calculation). |
| ✅ FCC/CE/RoHS Reports | ❌ Not Applicable | Medical devices follow FDA/MDR, not consumer electronics standards. |
| ✅ Packing List | ✔️ | Show units, net/gross weight, and batch/lot numbers. |
✅ 2. Declaration Tips (Key Mantras)
🔥 "Catgut is Pharma, Needle is Instrument, Sterile is Key, FDA is King!"
| Scenario | Correct Declaration | Wrong Practice |
|---|---|---|
| Catgut Sutures (no needle) | 3006.99.50.00 |
Misclassifying as 9018 → Delay |
| Sutures with Needle | 9018.39.00.00 |
Misclassifying as 3006 → Penalty |
| Hemostatic Gauze/Matrix | 3006.99.50.00 |
Misclassifying as 6307 → High Risk |
| Surgical Clamps (Tool) | 9018.90.90.00 |
Confusing tool with material |
✅ 3. Special Case Handling
| Scenario | Handling Advice |
|---|---|
| OEM/Private Label | Provide manufacturer authorization and FDA listing proof under your brand. |
| Non-Sterile Gut | Rare for surgical use. If non-sterile, it may be classified differently and face stricter import controls. Ensure Sterile. |
| Synthetic Absorbable (Vicryl/PDS) | Also often falls under 3006.99.50.00 or 9018.39.00.00. Same tariff rate (45%). |
| Medical Device Exemption | No general exemption for medical supplies from Section 301/IEEPA tariffs unless specifically excluded (very rare for sutures). |
🌍 V. Global Market Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff | Certification | Notes |
|---|---|---|---|---|
| 🇺🇸 USA | 3006.99.50.00 |
45% (CN Origin) | FDA 510(k)/Listing | High tariff due to Section 301 |
| 🇨🇳 China | 3006.99.50.00 |
6.5% | NMPA (CFDA) | Domestic production favored |
| 🇪🇺 EU | 3006.99 |
0% (if MDR compliant) | CE Mark (MDR) | No additional surtaxes |
| 🇬🇧 UK | 3006.99 |
0% (if UKCA) | UKCA Mark | Post-Brexit rules apply |
| 🇯🇵 Japan | 3006.99 |
0% | PMDA Approval | No surtaxes |
📌 Conclusion:
- USA is the only major market imposing a 45% tariff on Chinese-made gut hemostatic materials.
- EU and Japan remain tariff-free (if compliant with medical regulations), making them more attractive for cost-sensitive markets.
📌 VI. Common Errors & Pitfalls (Blood Lessons)
❌ Error 1: Classifying as "Textile Product" (Chapter 63)
👉 Consequence: FDA detention + Back taxes + Penalties. Catgut is a medical/pharmaceutical product, not a textile.
❌ Error 2: Omitting "Sterile" in Description
👉 Consequence: Customs may suspect non-medical grade, leading to inspection delays or rejection.
❌ Error 3: Confusing "Hemostatic Material" with "Hemostat Tool"
👉 Consequence: Wrong HS Code. Material = 3006/9018; Tool = 9018.90. Different tariffs and regulations.
❌ Error 4: Assuming "Medical Exemption" from Section 301
👉 Consequence: No exemption for most catgut sutures. Prepare for 45% cost.
✅ Correct Description Example:
"STERILE Chromic Catgut Surgical Suture, Absorbable, for Soft Tissue Approximation and Ligation, Medical Device, FDA Listed, Model XYZ, Batch No. ABC"
🎯 VII. Conclusion: Professional Declaration, Save Time and Money!
🎯 Remember the Mantra:
🔹 "Catgut is 3006, Needle is 9018, Sterile is Mandatory, FDA is Key!"
🔹 "45% Tariff in USA, Plan Ahead, Avoid Detention, Ensure Profit!"
📌 Pro Tip:
If your gut hemostatic material is manufactured in Vietnam, India, or Thailand, you may avoid the IEEPA/Section 301 surcharges, reducing the tariff to 0%~10%.
✅ Recommendation: Apply for Advance Ruling with US CBP if unsure about classification.
📣 Immediate Action:
📞 Contact a Licensed Customs Broker + Provide FDA Listing Number + Verify Sterilization Method
🚀 Ensure your Gut Hemostatic Material clears US Customs smoothly, minimizing costs and delays!
✨ Professional Customs Clearance Starts with Accurate Classification!
💼 Your Margins Depend on Precision!
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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。