Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042872931

FEI Number

3042872931

Entity Name

STEVIMED MEDICAL JOINT STOCK COMPANY

City/State/Country

Can Giuoc Long An, VN

Establishment Address

K2-5 Tan Kim Industrial Park Expansion, Can Giuoc Commune, Can Giuoc Long An 850000, VN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Stevimed Medical Joint Stock Company (Owner Number: 10094663)

Owner / Operator Contact Address

K2-5 Tan Kim Industrial Park Expansion, Can Giuoc Commune, Can Giuoc, VN-41 850000, VN

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
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2025-12-15
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2025-12-15
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2025-12-15
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2025-12-15

Official Correspondent

Laura Boll

US Agent Details

Laura Boll Business: Diversatek Healthcare Email: lboll@diversatek.com Phone: (414) 7554806

Related Public Records

Same Entity

Stevimed Medical Joint Stock Company

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
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

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1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US
3006950086	Merit Medical Nederland BV	Maastricht Airport Limburg, NL
1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042872931. Last updated year: 2026. Please use registration number 3042872931 when referencing this establishment in official correspondence.