Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012892649

FEI Number

3012892649

Entity Name

NINGBO INCOTE PRECISION MACHINERY CO., LTD.

City/State/Country

Ningbo City Zhejiang, CN

Establishment Address

No.1,Wuxiang North Road,, Wuxiang Industry Zone, Ningbo City Zhejiang 315111, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ningbo Incote Precision Machinery Co., Ltd. (Owner Number: 10091589)

Owner / Operator Contact Address

No.1,Wuxiang North Road,, Wuxiang Industry Zone, Ningbo City, CN-ZJ 315111, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

APTIMAX Instrument Tray or ULTRA GI Cycle model:011077-50

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2024-10-17
MLR	Sterilizer, Chemical	General Hospital	Class 2	880.6860	2024-10-17

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

Ningbo Incote Precision Machinery Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2014	Advanced Sterilization Products	2	STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0044-2014	Advanced Sterilization Products	2	STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012892649. Last updated year: 2026. Please use registration number 3012892649 when referencing this establishment in official correspondence.