OFFICIAL OPENFDA FEI RECORDFEI: 3012329926Reg Yr: 2027Taiwan (TW)

UNITED ORTHOPEDIC CORPORATION

Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for UNITED ORTHOPEDIC CORPORATION (FEI 3012329926). 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

57 Park Ave. 2, Science Park

Hsinchu Hsinchu(County), Taiwan (TW NOTA300)

FDA FURLS Identifiers

FEI Number: 3012329926

Registration No: 3012329926 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

Calvin Lin

UOC USA INC.

Irvine, CA (USA)

949-3283366

calvin.lin@unitedorthopedic.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

U1 Hip System - BipolarU1 Bipolar System

Product Code	FDA Classification Name	Device Class	21 CFR Regulation	510(k) Exempt?
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class 2	21 CFR 888.3390	Requires 510(k) / Check

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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., 3012329926) 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.

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Frequently Asked Questions: FEI 3012329926 (UNITED ORTHOPEDIC CORPORATION)

What is the FDA FEI Number for UNITED ORTHOPEDIC CORPORATION?

According to public US FDA Establishment Registration records, UNITED ORTHOPEDIC CORPORATION (Hsinchu Hsinchu(County), Taiwan) is assigned FDA Facility Establishment Identifier (FEI) 3012329926 (Registration No. 3012329926) with registration year 2027.

Who is the designated US Agent for FEI 3012329926 (UNITED ORTHOPEDIC CORPORATION)?

The registered US Agent on file for FEI 3012329926 is Calvin Lin (UOC USA INC.) located in Irvine, CA. Importers should independently confirm active representation before filing CBP ACE entry.

Does an active FDA FEI registration guarantee that shipments from UNITED ORTHOPEDIC CORPORATION 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.