SYSTEM STATUS: FDA ACTIVE ISO 13485 Valid MDR Ready
Establishment SinoTitanium
Metals
FEI No. 3033849259
Status Valid
[ISO 13485:2016 VERIFIED] // VDS- PROTOCOL ACTIVE
Sync Status: CBP-V2.1 Global Active

Customs & Import Compliance Database.

Precision in paperwork is as critical as precision in manufacturing. Access the forensic codes required for seamless "Green Lane" entry into US and Global markets.

FDA Establishment Verified HTS 2025 Updated

01 US Regulatory Terminal (FDA/CBP)

Medical device imports into the United States require precise classification under FDA regulation. Incorrect product codes are the #1 cause of "Hold and Detain" (FD1) events.

Official Entry Data
Data Requirement Forensic Value Verification Status
FDA Product Code EKO VERIFIED ACTIVE
Regulation Number 21 CFR 872.3600 Prosthesis, Solid, Dental
Manufacturer MID Code CNSINTIM123XIA SinoTitanium Xi'an
FDA Establishment FEI 3033849259 Annual Registration Active

Risk Alert: Improper HTS Usage

"Do not use generic HTS 8108.90 for finished dental blanks. This triggers a classification audit. ValidTi shipments are optimized for HTS 8108.90.30 (Wrought Rods/Bars) or 8108.90.60 (Finished Shapes) depending on the region."

Forensic MID Anatomy

CN - Country Origin China
SINTIM - Mill Identifier SinoTitanium
XIA - Region Xi'an, China
CBP Green Lane Status

ValidTi maintains a 99.8% first-pass clearance rate. Our automated documentation system generates a CBP-compliant "Forensic Entry Package" for every order.

Request Entry Sample →

02 Global HTS Classification Matrix

Primary Harmonized Codes

8108.90.30 Titanium Wrought Rods/Bars
US/EU/AS
8108.90.60 Titanium Finished Shapes (Discs)
US/EU
9021.29.00 Dental Fittings (Finished Abutments)
GLOBAL

Duty Exemption Status

ValidTi facilitates "Section 301" and "MDR Annex I" duty mitigation documentation for qualifying importers. Our Xi'an factory origin is certified via CCPIT (China Council for the Promotion of International Trade).

COO Origin Verified
DAP/CIF Logistics Terms

03 Regional Entry Document Matrix

Import Region Critical Requirement Document Type ValidTi Provision
United States FDA Product Code (EKO) Digital FDA Entry SYNC: 100% READY
European Union MDR Technical File Ref. Declaration of Conformity ANNEX I MAPPED
Brazil (ANVISA) Origin Verification Consular Legalized COO REQUEST BASED
Middle East Health Ministry Auth. Free Sale Certificate AVAILABLE (Xi'an Mill)

Request Regional Entry Kit

Our regulatory team assists authorized distributors with health ministry registrations and customs classification appeals. Request your "Forensic Entry Kit" for your specific region.

Direct Secure Access // VDS-IMPORT-READY

Logistics & Compliance Resources