Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043041723

FEI Number

3043041723

Entity Name

SP-Meditec

City/State/Country

Peachtree City, GA, US

Establishment Address

782 Highway 74 S, Peachtree City, GA 30269, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SP Meditec (Owner Number: 10095075)

Owner / Operator Contact Address

782 S Hwy 74, Peachtree City, GA 30269, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dansac Pouch Clamp Tube Adaptor Drainable Pouch Clamp CAD Loop Ostomy Bridge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2026-01-21
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	2026-01-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SP Meditec

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-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043041723. Last updated year: 2026. Please use registration number 3043041723 when referencing this establishment in official correspondence.