Tijuana, Baja California, Mexico (MX)FEI: 3014920188DUNS: 812940112Class I/II Medical, Dental & Aesthetic Devices

Tijuana Baja MedTech Assemblies S.A. de C.V.

Raw CBP/OASIS Entity String: TIJUANA BAJA MEDTECH ASSEMBLIES S.A. DE C.V.

FSVP Lead Auditor Note: Nearshore ISO 13485 medical disposable and catheter kit maquiladora serving US hospital distributors. Low risk score; single historical hold stemmed from a broker inputting an expired device listing code on a new SKU.

Primary US Port

Los Angeles

Last FDA Inspection

2026-01-22

VAI (Voluntary Action Indicated)

Detained Cargo Value

$31,500

Across 1 holds

Est. US Containers/Yr

~420 TEUs

CBP ACE Bill of Lading

Composite Procurement RiskMODERATE

24/ 100 Risk Score

5-Year Import Refusals:1

Active Warning Letters:0

FDA Enforcement Recalls:0

Green List — Active FURLS Registration & 510(k) Contract Maquiladora

Shipment Held? Request 24h Legal Review

6-Month Port Detention vs. Cleared Entry Velocity (Los Angeles)

Source: CBP ACE Manifest + FDA OASIS Refusal Feed

May 2026

0 Held36 Cleared

Hold Rate: 0%

Jun 2026

0 Held38 Cleared

Hold Rate: 0%

Jul 2026

0 Held35 Cleared

Hold Rate: 0%

Aug 2026

1 Held34 Cleared

Hold Rate: 3%

Sep 2026

0 Held39 Cleared

Hold Rate: 0%

Oct 2026

0 Held37 Cleared

Hold Rate: 0%

Dataset 1 of 3 • FDA OASIS Import Refusals

Historical Port Detentions & Refusal Dispositions (1)

Entry # & Date	Port	Detained Product & FDA Code	Charge Code & Import Alert	Cargo Value	Final CBP/FDA Disposition
W94-8501920-2 2025-10-15	Los Angeles	Sterile Ultrasonic Dental Scaler Handpiece Tip Kit FDA Product Code: 76E	NO_510K Import Alert 89-08	$31,500	Released After Form 766 Relabeling

Dataset 2 of 3 • CDER / CFSAN / CDRH Enforcement

FDA Warning Letters & Form 483 Citations (0)

No active FDA Warning Letters recorded for FEI #3014920188 in the last 5 years.

Dataset 3 of 3 • RES Recall Enterprise System

5-Year US Market Recalls (0)

Zero Class I, II, or III FDA product recalls linked to FEI #3014920188.

Plain-English Statutory Translation & Importer Action Plan

Cited FDA Charge Codes & Remediation Checklists for Tijuana Baja MedTech Assemblies S.A. de C.V.

NO_510K (FD&C Act Section 510(k))Form FDA 766 Relabeling Eligible

Adulterated / Misbranded Device: Lacks cleared Premarket Notification 510(k)

A Class I/II medical or aesthetic device was shipped to a US port without a valid FDA 510(k) clearance number or establishment registration.

Importer Remediation Checklist:

Verify the manufacturer's Establishment Registration & Device Listing (FEI number) in FDA FURLS.
Confirm whether the device claims fall under a 510(k)-exempt product code.

Typical Hold: 18–32 calendar daysView Full NO_510K Form 766 Playbook →

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Full 5-year OASIS refusal history for Tijuana Baja MedTech Assemblies S.A. de C.V. + category peers
21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab

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FEI #3014920188 Watchdog$15 / month

Instant Supplier Detention Webhook & Email Alert Monitor

Get an automated Slack/Webhook JSON payload and email alert within 15 minutes whenever FDA OASIS logs a new detention, Import Alert Red List addition, or Warning Letter for Tijuana Baja MedTech Assemblies S.A. de C.V. before you wire your 70% balance payment.

TIER 3 • URGENT US FDA COMPLIANCE COUNSEL DISPATCH (CPL VERIFIED)

Respond-By Deadline Priority Triage

Shipment Detained by FDA or Placed on Import Alert? Request Free 24h Detention Evaluation from Licensed US FDA Compliance Counsel

When FDA issues a Notice of FDA Action (Detention), importers typically have only 10 to 20 business days to file a Form FDA 766 relabeling application, submit an accredited private laboratory packet (PLAP), or petition for Import Alert Red List removal before CBP orders refusal and liquidated damages.

Your Full Name & Role (Required)

Include your name and title (e.g., “Sarah Chen, VP Supply Chain”).

Please provide your full name (at least 2 characters).

Work Email for 24h Legal Memo (Required)

Used strictly to deliver your conflict-free 24h FDA detention evaluation.

Please enter a valid corporate email address.

Importer Website or Amazon/Shopify Store URL (Required)

Include https:// so counsel can pre-screen product Intended Use claims.

Please enter a valid URL starting with https:// or http://.

CBP Entry Number or Supplier FEI # (Required)

Format: 10-digit FEI (e.g., 3014920188) or 11-char CBP Entry # (e.g., W94-8829104-3).

Enter a 5–24 character alphanumeric FEI number or CBP Entry number.

US Port of Detention

Select the FDA District / Port holding the cargo.

Primary Cited FDA Charge Code

Charge listed on your Notice of FDA Action.

Commercial Cargo Value at Risk

Determines Form 766 vs. PLAP economic viability.

Notice of FDA Action Summary & Respond-By Date (Optional)

Describe whether cargo is currently on hold in ITACS, whether private lab sampling has started, or if you need an Import Alert removal petition.

🔒 Confidential submission • Zero upfront cost for 24h detention evaluation • Matched with licensed US FDA / Customs attorneys.

Compare Alternative Suppliers in Class I/II Medical, Dental & Aesthetic Devices

View Category Detention Report →

Shenzhen MedOptic Photon Technology Co., Ltd.

China • FEI 3016729104 • Red List — Import Alert 89-08 (Device Without Cleared 510(k))

100/100

Tijuana Baja MedTech Assemblies S.A. de C.V. Compliance FAQ

Is Tijuana Baja MedTech Assemblies S.A. de C.V. (FEI 3014920188) on an FDA Import Alert Red List?

Tijuana Baja MedTech Assemblies S.A. de C.V. currently carries a Composite FDA Risk Score of 24/100 (MODERATE) in DWPERadar records with status: Green List — Active FURLS Registration & 510(k) Contract Maquiladora. Primary US port of entry is Los Angeles. Historical records are informational only and should be cross-checked on official FDA dashboards before CBP filing.

What are the main FDA Charge Codes cited against Tijuana Baja MedTech Assemblies S.A. de C.V.?

Across the 5-year OASIS refusal dataset, Tijuana Baja MedTech Assemblies S.A. de C.V. has been cited for NO_510K. Importers should review the statutory remediation checklists and Form FDA 766 eligibility before filing CBP entry.