Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008388005

FEI Number

3008388005

Entity Name

SINAPI BIOMEDICAL (PTY) LTD

City/State/Country

Stellenbosch Western Cape, ZA

Establishment Address

ARC-Infruitec North Campus, Lelie Road, Stellenbosch Western Cape 7600, ZA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sinapi Biomedical (PTY) LTD (Owner Number: 10032397)

Owner / Operator Contact Address

ARC-Infruitec North Campus, Lelie Road, Stellenbosch, ZA-NOTA 7600, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SINAPI Urine Meter

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	2013-01-15
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Gastroenterology, Urology	Class 2	876.1800	2010-10-15
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2014-02-12

Official Correspondent

Chris De Villiers

US Agent Details

Sanjiv Kumar Business: Myco Medical Supplies, Inc. Email: skumar@mycomedical.com Phone: (800) 4546926

Related Public Records

Same Entity

Sinapi Biomedical (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
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

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 3008388005. Last updated year: 2026. Please use registration number 3008388005 when referencing this establishment in official correspondence.