Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042226212

FEI Number

3042226212

Entity Name

PT. CIPTA KARYA BUANA

City/State/Country

Sidoarjo Jawa Timur, ID

Establishment Address

Jl. Raya By Pass KM. 32, Balongbendo, Sidoarjo Jawa Timur 61263, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PT. Cipta Karya Buana (Owner Number: 10094299)

Owner / Operator Contact Address

Jl. Raya By Pass KM. 32, Balongbendo, Sidoarjo, ID-JI 61263, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2025-11-21

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

PT. Cipta Karya Buana

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042226212. Last updated year: 2026. Please use registration number 3042226212 when referencing this establishment in official correspondence.