Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004899005

FEI Number

3004899005

Entity Name

MEDI-SAFE SURGICALS (PTY) LTD.

City/State/Country

Paardevlei Western Cape, ZA

Establishment Address

Tonquani House, 6 Gardner Williams Ave., Paardevlei Western Cape 7110, ZA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Medi-Safe Surgicals (PTY) Ltd. (Owner Number: 9068635)

Owner / Operator Contact Address

Tonquani House, 6 Gardner Williams Ave., Paardevlei, ZA-WC 7110, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

REDI-CUT SHEATH SAFETY SCALPEL Technocut Plus Retractable Safety Scalpels RELI-CUT RETRACTABLE SAFETY SCALPEL Technocut Pro Blade Management System (BMS) Cartridges GLASSVAN BMS CARTRIDGE MEDI-SAFE RETRACTABLE SAFETY SCALPEL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2004-12-01

Official Correspondent

No official correspondent registered.

US Agent Details

SANJIV KUMAR Business: MYCO MEDICAL SUPPLIES, INC. Email: qa@mycomedical.com Phone: (919) 4602535

Related Public Records

Same Entity

Medi-Safe Surgicals (PTY) 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-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

Registration Number	Establishment Name	Location
3040389290	HUAIYIN MEDICAL INSTRUMENTS CO., LTD.	Huai an City Jiangsu, CN
3014649053	Sterilance Medical (Suzhou) Inc.	Suzhou Jiangsu, CN
3013557562	CBR ENTERPRISE LIMITED	Hong Kong, HK
3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US
3016844398	AG MARKETING & DEVELOPMENT GROUP INC DBA AGMD GROUP	Brampton Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004899005. Last updated year: 2026. Please use registration number 3004899005 when referencing this establishment in official correspondence.