Data / Medical devices / Dominican Republic / Das Medical International, SRL

Das Medical International, SRL: FDA-registered device maker in La Romana, Dominican Republic, 3 510(k) clearances

Name: Das Medical International, SRL FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Das Medical International, SRL is registered with the FDA (registration 3010193531) in La Romana, Dominican Republic. It lists 15 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 3, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3010193531
Address: Industrial Free Zone II, La Romana, Dominican Republic, 22000
Owner or operator: DAS Medical International SRL (10036300)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: February 9, 2014
Registered through: 2026
Brand names listed: 0120 Band Bag 36" X 20, 0120X Band Bag With Tape Tabs on Corners 36" X 20, 0130 Band Bag 36 x 30, 0136 Band Bag 36 x 36, 0141 Band Bag 36 x 41, 0184 Band Bag 36 x 25, 021655 R1 Arm Drape, 0284 Handle Cover/Band Bag 7 x 9 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Contract manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Collector, Urine, Powered, Non Indwelling Catheter	NZU	1	Contract manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Drape, Urological, Disposable	EYY	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Integrated Operating Table-Electromechanical Surgical System	SIR	2	Contract manufacturer	accessdata.fda.gov
Modular Electromechanical Surgical System	SCV	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler	accessdata.fda.gov
System, Surgical, Computer Controlled Instrument	NAY	2	Contract manufacturer	accessdata.fda.gov
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	NNZ	1	Contract manufacturer	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Manufacturer	accessdata.fda.gov
Table, Cysto, Non-Electrical	EYH	1	Manufacturer	accessdata.fda.gov
Table, Cystometric, Electric	MMZ	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Contract manufacturer	accessdata.fda.gov
Warmer, Irrigation Solution	LHC	1	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 3, 2025	K250725	Hugo RAS System	SCV	Substantially Equivalent	Covidien, LLC	accessdata.fda.gov
March 14, 1996	K953673	ECLIPSE PROBE COVER	IYO	Substantially Equivalent	Parker Laboratories, Inc.	accessdata.fda.gov
November 1, 1985	K853044	STERICOVER	IZI	Substantially Equivalent	Sterimed, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.