Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034693330

FEI Number

3034693330

Entity Name

CARETECH HUMAN INC

City/State/Country

Ithaca, NY, US

Establishment Address

407A Weill Hall, 237 Tower Rd, Weill Hall 407A, Center for Life Science Ventures, Cornell University, Ithaca, NY 14853, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

CareTech Human Inc (Owner Number: 10092005)

Owner / Operator Contact Address

407A Weill Hall, 237 Tower Rd, Weill Hall 407A, Center for Life Science Ventures, Cornell University, Ithaca, NY 14853, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Urowell

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2024-11-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CareTech Human Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3021192255	FIZE Medical LTD.	Modiin Central, IL
3029753827	BRIGHT URO, INC.	Irvine, CA, US
3020978007	DONGGUAN BAO KANG DIAN ZI KE JI LIMITED	Dongguan City Guangdong, CN
3011383638	POTRERO MEDICAL, INC.	Hayward, CA, US
3031976597	Nextern	Maple Grove, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034693330. Last updated year: 2026. Please use registration number 3034693330 when referencing this establishment in official correspondence.