ACHB ENTERPRISE CO., LTD.

FDA Device Registration & Listing · Tainan, TW · Registration 3013400623

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013400623
FEI Number
3013400623
Entity Name
ACHB ENTERPRISE CO., LTD.
City/State/Country
Tainan, TW
Establishment Address
No. 12, Minsheng Rd., Baoan Vil., Rende Dist., Tainan City 71750, Taiwan, Tainan 71750, TW
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ACHB Enterprise Co., Ltd. (Owner Number: 10086038)
Owner / Operator Contact Address
No. 12, Minsheng Rd., Baoan Vil., Rende Dist., Tainan City 71750, Taiwan, Tainan, TW-TNN 717010, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Uro Checker

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EXR Urinometer, Mechanical Gastroenterology, Urology Class 2 876.1800 2022-10-12

Official Correspondent

No official correspondent registered.

US Agent Details

Richard Young Business: D.Y. Component Sourcing, LLC Email: dyoung@dycsllc.com Phone: (603) 8819411

Related Public Records

Same Entity

ACHB Enterprise Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3023229466 ISHIDA MEDICAL LLC Irvine, CA, US
9612030 Cardinal Health (Kenmex Medical Specialties) TIJUANA Baja California, MX
8010061 NIHON SEIMITSU SOKKI CO., LTD. SHIBUKAWA Gunma, JP
1921846 Cardinal Health Hazelwood, MO, US
3006082230 C.R. BARD, INC. MADISON, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013400623. Last updated year: 2026. Please use registration number 3013400623 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.