FDA Biennial Registration Renewal of 2020

Your next FDA Biennial Registration Renewal is between October 1 and December 31, 2020.

Why wait until October 1, 2020? Prepay now and save extra cash.

www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com

When you are competing with 300,000+ companies to renew your FDA REGISTRATION, be smart about it.

What to do in the meantime?

Check our Specials

■ Switch U.S. Agent
Limited Offer – $99.00 for Food and Supplements Companies

FDA Registration Number : why pay more for less?

■ Need Food or Supplements Label Review / Design?
Limited Offer – $99.00


What are your options?


ITB HOLDINGS LLC: Select us as your U.S. Agent

Ask for an invoice: Send us an email now

Emails without full company name (as registered), street address, city, postal / zip code, country and telephone number will be automatically deleted as junk or spam.

$99.00: to get you started

❹ Sit back and relax, then receive your FDA Registration Number within 72 hours (Standard Service) or sooner.

Want your company’s FDA Registration Number the same day? Make a request: $198.00.

You cannot find this deal anywhere else.

Contact ITB HOLDINGS LLC at T : +1 855 510 2240 | T : +1 855 389 7344 | T : +44 800 610 1577 | FDA REGISTRATION for 99 Dollars


What’s included?


■ Food Facility Registration

■ Supplement Facility Registration

■ U.S. Agent Service (Foreign Companies)


Any extras? Sure


Prior Notice

■ Foreign Supplier Verification Program – FSVP

■ Registration Certificate

Supplement Facts Label

Nutrition Facts Label


REQUIRED INFORMATION


■ Full company’s name (as registered locally)

■ Street address, city, postal / zip code, state, country

■ Full name of CEO / Manager

■ Telephone number of CEO / Manager

■ Email of CEO / Manager

■ Product details.


EBAY SHOPPERS: CHECKOUT NOW


Companies can export or import Foods | Dietary Supplements | Alcoholic Beverages | to or from the United States as long as the facilities that produce, store, or otherwise handle the products are registered with the FDA (Food and Drug Administration), and prior notice of incoming shipments is provided to the FDA.


Additional Services

■ FDA Registration
■ Product Listing
■ U.S. Agent Service

» Food Canning

» Drugs

» Medical Devices

» OTC Cosmetics

$350.00 | Limited Offer


Thank you for your business

Join our satisfied clients in 100 countries including China | Japan | South Korea | Germany | France | United Kingdom | Canada | Mexico | Spain | Portugal | Italy | Greece | Netherlands | Belgium | Sweden | Australia | New Zealand | Ireland | Poland | Romania | Russia | Ukraine | India | Pakistan | Taiwan | Brazil | United States.

Our representatives are standing by for any question.


Foreign Languages


Español

Deutsch

Français

Italiano

Nederlands

Português

Русский

中文

Contáctenos | お問い合わせ | 联系我们 | Contact met ons opnemen | Contattaci | связаться с нами | हमसे संपर्क करें | اتصل بنا | Contactez-nous | Kontaktieren Sie uns | Kontakta oss | Kontakt z nami | Kontaktujte nás.


MORE INFORMATION?

www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com


Contact us today.

EXTENDED OFFICE HOURS

3:00 AM – 6:00 PM

Eastern Standard Time – EST

Monday – Sunday

Multilingual and International Team to handle your requests within hours, not days.

LIVE CHAT available on all websites

FOLLOW US

TwitterLinkedinFacebook


ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype Chat: itbholdings
itbholdings | Skype Call

FDA Registration of Medical Devices

Premarket Notification 510(k) | Premarket Approval (PMA) | Establishment Registration | www.itbhdg.com

If you’re planning to grow in size, profits, or into new markets, consider expanding to or within the United States.

More than 24,584 domestic (12,848) and foreign (11,736) medical device establishments are registered with FDA.

LIMITED OFFER

✔ Establishment Registration

✔ Medical Device Listing

✔ U.S. Agent Service (Foreign Companies)

✔ $350.00 USD | Initial Registration Fee

✔ $300.00 USD | Annual Fee

Government Fees are extra

Premarket Notification 510(k)

Premarket Approval (PMA)



FDA COMPLIANCE

Owners or operators of companies that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the U.S. FDA (Food and Drug Administration) and list the devices that are made there. This process is known as establishment registration.

Companies required to register their establishments and list their devices with the FDA

Firms that

* manufacture
* repackage and relabel
* develop specifications
* reprocess single-use devices
* remanufacture
* manufacture accessories and components sold directly to the end user.


WHAT’S INCLUDED?


⚾ U. S. Agent service

⚾ Medical Device Establishment registration

⚾ Medical Device listing

⚾ Classification of your medical device to determine the proper FDA product code and regulation number.

⚾ Determination of similar (predicate) devices with 510(k) clearance and whether they are suitable for use in your 510(k) submission.

⚾ Completion of 21 sections of the 510(k) application.

⚾ Payment of 510(k) fees on your behalf (when needed).

⚾ Electronic filing of the 510(k) and follow-up with the FDA reviewer.


We speak English, Dutch , French, Spanish, for your convenience.

DEUTSCH | GERMAN

FDA Registrierung

NEDERLANDS | DUTCH

FDA Registratie

ESPAÑOL | SPANISH

Registro FDA

FRANÇAIS | FRENCH

Enregistrement FDA


MORE INFORMATION? Contact us today.

EXTENDED OFFICE HOURS : 3:00 AM – 6:00 PM

Eastern Standard Time – EST

Monday – Sunday

Multilingual and International Team to handle your requests within hours, not days.

LIVE CHAT is available on all websites

 

www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com

FDA Registration of your Medical Device Company and Products | www.m.itbhdg.com | www.itbhdg.com

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings