OFFICIAL OPENFDA FEI RECORDFEI: 3010300212Reg Yr: 2026South Korea (KR)

Samsung Electronics Co., Ltd.

Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for Samsung Electronics Co., Ltd. (FEI 3010300212). 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

129, Samsung-ro, Yeongtong-gu

Suwon-si Gyeonggi, South Korea (16677)

FDA FURLS Identifiers

FEI Number: 3010300212

Registration No: 3010300212 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

Ninad Gujar

Samsung HME America, Inc.

Danvers, MA (USA)

978-5648632

ngujar@neurologica.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.

Proprietary / Commercial Brand Names on File

AccE GM85; GM85; GM85 with Lite; GM85 with Prestige

Product Code	FDA Classification Name	Device Class	21 CFR Regulation	510(k) Exempt?
IZL	System, X-Ray, Mobile	Class 2	21 CFR 892.1720	Requires 510(k) / Check

FSVP AUDIT WORKBOOKS & REAL-TIME OASIS DETENTION ALERTSFEI #3010300212 • 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 Samsung Electronics Co., Ltd. (FEI 3010300212) + 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 #3010300212 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 Samsung Electronics Co., Ltd. (FEI 3010300212) 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., 3010300212) 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 South Korea

FEI 3011189058

Ewoosoft Co., Ltd

Hwaseong-si Gyeonggi, South Korea • Reg Yr 2026

FEI 3014389257

YBRAIN INC.

Daejeon, South Korea • Reg Yr 2027

FEI 3015542154

Zimmer Biomet Korea Ltd.

Seoul, South Korea • Reg Yr 2027

FEI 3013501671

LG ELECTRONICS INC.

Gumi-si Gyeongbuk, South Korea • Reg Yr 2027

FEI 3004578807

DENTIUM CO., LTD.

Suwon-si Gyeonggi, South Korea • Reg Yr 2027

FEI 3000247987

SEWOON MEDICAL CO., LTD.

Cheonan-si Chungnam, South Korea • Reg Yr 2027

Frequently Asked Questions: FEI 3010300212 (Samsung Electronics Co., Ltd.)

What is the FDA FEI Number for Samsung Electronics Co., Ltd.?

According to public US FDA Establishment Registration records, Samsung Electronics Co., Ltd. (Suwon-si Gyeonggi, South Korea) is assigned FDA Facility Establishment Identifier (FEI) 3010300212 (Registration No. 3010300212) with registration year 2026.

Who is the designated US Agent for FEI 3010300212 (Samsung Electronics Co., Ltd.)?

The registered US Agent on file for FEI 3010300212 is Ninad Gujar (Samsung HME America, Inc.) located in Danvers, MA. Importers should independently confirm active representation before filing CBP ACE entry.

Does an active FDA FEI registration guarantee that shipments from Samsung Electronics Co., Ltd. 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.