OFFICIAL OPENFDA FEI RECORDFEI: 3012842398Reg Yr: 2026Taiwan (TW)

DA TONG OPTICAL COMPANY LIMITED

Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for DA TONG OPTICAL COMPANY LIMITED (FEI 3012842398). Use this record to cross-check CBP ACE Affirmation of Compliance codes (`DEV` / `DFE` / `FEI`), verify the designated US Agent on file, and subscribe to automated Import Alert (DWPE) monitoring.

Registered Facility Address

14F-1, No.294, Sec.1, Tunhua S. Rd.

Taipei, Taiwan (10691)

FDA FURLS Identifiers

FEI Number: 3012842398

Registration No: 3012842398 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

Sandra Berggren

Seaver Company

Le Sueur, MN (USA)

507-6653321

sberggren@i-gogs.com

Registered FDA Product Codes, Device Classes & Commercial Names

Cross-check your commercial invoice product descriptions against these active FDA product code filings to prevent NO_510K or UNAPPROVED_NEW_DRUG port holds.

Product Code	FDA Classification Name	Device Class	21 CFR Regulation	510(k) Exempt?
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Class 1	21 CFR 886.4750	Requires 510(k) / Check

FSVP AUDIT WORKBOOKS & REAL-TIME OASIS DETENTION ALERTSFEI #3012842398 • Instant Delivery

5-Year Cleaned Excel Pack$39 One-Time

Download Normalized 5-Year Refusal, 483 & Recall Audit Workbook (.XLSX + CSV)

Includes all deduplicated overseas factory names, FEI/DUNS crosswalks, 5-year port refusal logs, plain-English statutory violation mappings, and FSVP supplier qualification templates ready for customs broker review.

Full 5-year OASIS refusal history for DA TONG OPTICAL COMPANY LIMITED (FEI 3012842398) + category peers
21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab

Buy Cleaned 5-Yr Excel ($39)PayPal.me ($39)

⬇ Download Audit Sample (.XLS Workbook)⬇ Download Audit Sample (UTF-8 .CSV)

FEI #3012842398 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 DA TONG OPTICAL COMPANY LIMITED (FEI 3012842398) before you wire your 70% balance payment.

URGENT U.S. FDA & CUSTOMS COMPLIANCE COUNSEL DISPATCH

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., 3012842398) 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.

Other Verified FDA FEI Establishments in Taiwan

FEI 3021032044

EverFortune.AI Co., Ltd.

TAICHUNG CITY, Taiwan • Reg Yr 2026

FEI 3031369651

HSINER CO., LTD.

Taichung City, Taiwan • Reg Yr 2026

FEI 3012329926

UNITED ORTHOPEDIC CORPORATION

Hsinchu Hsinchu(County), Taiwan • Reg Yr 2027

FEI 3003772414

TOP LONGMAX PRODUCTS CO., LTD.

TAICHUNG, Taiwan • Reg Yr 2026

FEI 3039346136

YANKANG MEDICAL INSTRUMENT CO., LTD.

Taipei, Taiwan • Reg Yr 2026

Frequently Asked Questions: FEI 3012842398 (DA TONG OPTICAL COMPANY LIMITED)

What is the FDA FEI Number for DA TONG OPTICAL COMPANY LIMITED?

According to public US FDA Establishment Registration records, DA TONG OPTICAL COMPANY LIMITED (Taipei, Taiwan) is assigned FDA Facility Establishment Identifier (FEI) 3012842398 (Registration No. 3012842398) with registration year 2026.

Who is the designated US Agent for FEI 3012842398 (DA TONG OPTICAL COMPANY LIMITED)?

The registered US Agent on file for FEI 3012842398 is Sandra Berggren (Seaver Company) located in Le Sueur, MN. Importers should independently confirm active representation before filing CBP ACE entry.

Does an active FDA FEI registration guarantee that shipments from DA TONG OPTICAL COMPANY LIMITED will clear US Customs without detention?

No. An active FDA FEI number or establishment registration only confirms administrative listing in FDA FURLS. Shipments can still be detained at US ports under Detention Without Physical Examination (DWPE / Import Alerts) for labeling, 510(k), cGMP, or adulteration violations.