OFFICIAL OPENFDA FEI RECORDFEI: 3002807687Reg Yr: 2027Japan (JP)

NAKANISHI INC.

Official US Food and Drug Administration (FDA) Establishment Registration & Device/Facility Listing dossier for NAKANISHI INC. (FEI 3002807687). 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

700 SHIMOHINATA

Kanuma Tochigi, Japan (322-8666)

FDA FURLS Identifiers

FEI Number: 3002807687

Registration No: 9611253 • Status Code: 1 (Active)

Designated U.S. Agent21 CFR 807.40

SEAN KAUFMAN

NSK AMERICA CORPORATION

Hoffman Est, IL (USA)

888-6751675

nskra@nsk-nakanishi.co.jp

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

P300-2S20P300-2S120P300-1T110P300-2S100P300-1T240

Product Code	FDA Classification Name	Device Class	21 CFR Regulation	510(k) Exempt?
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Class 2	21 CFR 874.4250	Requires 510(k) / Check
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class 1	21 CFR 878.4820	Requires 510(k) / Check
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Class 2	21 CFR 882.4310	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 NAKANISHI INC. (FEI 3002807687) before you wire your 70% balance payment.

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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., 3002807687) 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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Other Verified FDA FEI Establishments in Japan

FEI 3009761573

KANEKA MEDIX CORPORATION KANAGAWA PLANT

Ashigara-Kami-gun Kanagawa, Japan • Reg Yr 2027

FEI 3016527960

Sony Global Manufacturing & Operations Corporation Kohda Site

Nukata-gun Aichi, Japan • Reg Yr 2026

FEI 3014270673

Togo Medikit Co., Ltd. Medikit Hyuga Second Factory

Hyuga City Miyazaki, Japan • Reg Yr 2027

FEI 3002808328

TOSOH AIA, INC.

TOYAMA, Japan • Reg Yr 2026

Frequently Asked Questions: FEI 3002807687 (NAKANISHI INC.)

What is the FDA FEI Number for NAKANISHI INC.?

According to public US FDA Establishment Registration records, NAKANISHI INC. (Kanuma Tochigi, Japan) is assigned FDA Facility Establishment Identifier (FEI) 3002807687 (Registration No. 9611253) with registration year 2027.

Who is the designated US Agent for FEI 3002807687 (NAKANISHI INC.)?

The registered US Agent on file for FEI 3002807687 is SEAN KAUFMAN (NSK AMERICA CORPORATION) located in Hoffman Est, IL. Importers should independently confirm active representation before filing CBP ACE entry.

Does an active FDA FEI registration guarantee that shipments from NAKANISHI INC. 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.