Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010610457

FEI Number

3010610457

Entity Name

CENEFOM CORP

City/State/Country

Zhunan Township Miaoli, TW

Establishment Address

3F, No. 50-3, Keyan Rd., Zhunan Township Miaoli 35053, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Cenefom Corp. (Owner Number: 10045592)

Owner / Operator Contact Address

1F, No. 50-5, Keyan Rd., Zhunan Township, TW-MIA 350401, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CENEFOM Cenefom Cenefom Ophthalmic sponges Disposable Sampling Swab, Disposable Sterile Sampling Swab

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	Class 1	874.4780	2016-10-23
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-05-18
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2013-12-05
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-08-17
EMX	Balloon, Epistaxis	Ear, Nose, Throat	Class 1	874.4100	2013-12-05
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2023-02-21
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2023-08-17
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-05-12

Official Correspondent

Tommy Hsu

US Agent Details

Michael Zhao Business: Crius Pacific Medical Inc. Email: zhao@criuspacificmedical.com Phone: (650) 9425983

Related Public Records

Same Entity

Cenefom Corp.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010610457. Last updated year: 2026. Please use registration number 3010610457 when referencing this establishment in official correspondence.