OFFICIAL OPENFDA FEI RECORDFEI: 3009746061Reg Yr: 2027Mexico (MX)

Integra Biotechnical, SA de CV

Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for Integra Biotechnical, SA de CV (FEI 3009746061). 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

Privada Los Pinos #17030 Interior 15, 16, 17, Colonia Ninos Heroes Este, C.P, Ave. Via Rapida Poniente #16835 Interior 3, Centro Ind. Los Pinos II, Colonia Ninos Heroes Este, C.P.

Tijuana Baja California, Mexico (22120)

FDA FURLS Identifiers

FEI Number: 3009746061

Registration No: 3009746061 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

Lamont Rohde

Amphenol Critical Medical Technologies, LLC

San Diego, CA (USA)

602-7503539

lamont.rohde@amphenol-cmt.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

Tissue Catch with Suction TubingFluid Management AccessoryWaste Management AccessoryWaste Bag, 6L

Product Code	FDA Classification Name	Device Class	21 CFR Regulation	510(k) Exempt?
HIH	Hysteroscope (And Accessories)	Class 2	21 CFR 884.1690	Requires 510(k) / Check

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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 Integra Biotechnical, SA de CV (FEI 3009746061) 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.

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

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Work Email for 24h Legal Memo (Required)

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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., 3009746061) 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 3009746061 (Integra Biotechnical, SA de CV)

What is the FDA FEI Number for Integra Biotechnical, SA de CV?

According to public US FDA Establishment Registration records, Integra Biotechnical, SA de CV (Tijuana Baja California, Mexico) is assigned FDA Facility Establishment Identifier (FEI) 3009746061 (Registration No. 3009746061) with registration year 2027.

Who is the designated US Agent for FEI 3009746061 (Integra Biotechnical, SA de CV)?

The registered US Agent on file for FEI 3009746061 is Lamont Rohde (Amphenol Critical Medical Technologies, LLC) located in San Diego, CA. Importers should independently confirm active representation before filing CBP ACE entry.

Does an active FDA FEI registration guarantee that shipments from Integra Biotechnical, SA de CV 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.