EUDAMED update: Apr 28, 2026

WomanCare Global, LLC

US-MF-000042625

Active36 devices

Address: Roanoke Blvd, 1640 24153 Salem
Role: Manufacturer
Date of registration: Jun 17, 2024
Country: United States

WomanCare Global, LLC is a medical device manufacturer registered in EUDAMED. The company has 36 devices on the EU market in United States. Headquartered in Salem, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About WomanCare Global

: US-MF-000042625
Role: Manufacturer
Country: United States
Organization name: WomanCare Global, LLC
EU VAT number: Not applicable
EORI: Not available
Trade register: 93-1878347
Date of registration: Jun 17, 2024

Contact details for WomanCare Global

Phone: +33 1 42 47 09 68
Email: contact@dktwomancare.org
Website: https://www.dktwomancare.org/
Address: 1640, ROANOKE BLVD VA 24153 SALEM UNITED STATES

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Competent authority

Name: Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico

Phone: +39 06 5994 3199/ +39 06 5994 3207
Email: segr.dgfdm@sanita.it

Officers and regulatory representatives of WomanCare Global

AL-SHUWELI Suzan
The post-market surveillance obligations are complied with in accordance with Article 10(10) of the MDR.
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CHERKAOUI Fatima-Ezzahra
•The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. • The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. • The reporting obligations referred to in Article 87 to 91 of the MDR are fulfilled. • In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the MDR is issued.
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Connected operators

Importers

3 EU importers place this manufacturer's devices

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Adapter Set	Adapter Set	`ADP-SET`	`00853615006345`	1	On the market
3mm Cannula	3mm Cannula	`EB3`	`00853615006284`	1	On the market
6mm Adapter	6mm Adapter	`ADP-6MM`	`00853615006338`	1	On the market
Denniston Dilators	Denniston Dilators	`DD5-S`	`00853615006376`	1	On the market
Double Valve Aspirator	Double Valve Aspirator	`DVS-S10`	`10853615006366`	10	On the market
Double Valve Aspirator, unsterile	Double Valve Aspirator, unsterile	`DVS-SU`	`00853615006253`	1	On the market
Flexible Karman Cannula, size 10mm	Flexible Karman Cannula, size 10mm	`FC10`	`00853615006000`	1	On the market
Flexible Karman Cannula, size 12mm	Flexible Karman Cannula, size 12mm	`FC12`	`00853615006024`	1	On the market
Flexible Karman Cannula, size 4mm	Flexible Karman Cannula, size 4mm	`FC4`	`00853615006031`	1	On the market
Flexible Karman Cannula, size 5mm	Flexible Karman Cannula, size 5mm	`FC5`	`00853615006048`	1	On the market
Flexible Karman Cannula, size 6mm	Flexible Karman Cannula, size 6mm	`FC6`	`00853615006055`	1	On the market
Flexible Karman Cannula, size 7mm	Flexible Karman Cannula, size 7mm	`FC7`	`00853615006062`	1	On the market
Flexible Karman Cannula, size 8mm	Flexible Karman Cannula, size 8mm	`FC8`	`00853615006079`	1	On the market
Flexible Karman Cannula, size 9mm	Flexible Karman Cannula, size 9mm	`FC9`	`00853615006086`	1	On the market
Ipas EasyGrip® Cannula, size 10mm	Ipas EasyGrip® Cannula, size 10mm	`SR10`	`00853615006093`	1	On the market
Ipas EasyGrip® Cannula, size 10mm, Single-Use	Ipas EasyGrip® Cannula, size 10mm, Single-Use	`SR10-SU`	`00853615006109`	1	On the market
Ipas EasyGrip® Cannula, size 12mm	Ipas EasyGrip® Cannula, size 12mm	`SR12`	`00853615006116`	1	On the market
Ipas EasyGrip® Cannula, size 12mm, Single-Use	Ipas EasyGrip® Cannula, size 12mm, Single-Use	`SR12-SU`	`00853615006123`	1	On the market
Ipas EasyGrip® Cannula, size 4mm	Ipas EasyGrip® Cannula, size 4mm	`SR4`	`00853615006130`	1	On the market
Ipas EasyGrip® Cannula, size 4mm, Single-Use	Ipas EasyGrip® Cannula, size 4mm, Single-Use	`SR4-SU`	`00853615006147`	1	On the market
Ipas EasyGrip® Cannula, size 5mm	Ipas EasyGrip® Cannula, size 5mm	`SR5`	`00853615006154`	1	On the market
Ipas EasyGrip® Cannula, size 5mm, Single-Use	Ipas EasyGrip® Cannula, size 5mm, Single-Use	`SR5-SU`	`00853615006161`	1	On the market
Ipas EasyGrip® Cannula, size 6mm	Ipas EasyGrip® Cannula, size 6mm	`SR6`	`00853615006178`	1	On the market
Ipas EasyGrip® Cannula, size 6mm, Single-Use	Ipas EasyGrip® Cannula, size 6mm, Single-Use	`SR6-SU`	`00853615006185`	1	On the market
Ipas EasyGrip® Cannula, size 7mm	Ipas EasyGrip® Cannula, size 7mm	`SR7`	`00853615006192`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Adapter Set	Adapter Set	`ADP-SET`	`00853615006345`	1	On the market
3mm Cannula	3mm Cannula	`EB3`	`00853615006284`	1	On the market
6mm Adapter	6mm Adapter	`ADP-6MM`	`00853615006338`	1	On the market
Denniston Dilators	Denniston Dilators	`DD5-S`	`00853615006376`	1	On the market
Double Valve Aspirator	Double Valve Aspirator	`DVS-S10`	`10853615006366`	10	On the market
Double Valve Aspirator, unsterile	Double Valve Aspirator, unsterile	`DVS-SU`	`00853615006253`	1	On the market
Flexible Karman Cannula, size 10mm	Flexible Karman Cannula, size 10mm	`FC10`	`00853615006000`	1	On the market
Flexible Karman Cannula, size 12mm	Flexible Karman Cannula, size 12mm	`FC12`	`00853615006024`	1	On the market
Flexible Karman Cannula, size 4mm	Flexible Karman Cannula, size 4mm	`FC4`	`00853615006031`	1	On the market
Flexible Karman Cannula, size 5mm	Flexible Karman Cannula, size 5mm	`FC5`	`00853615006048`	1	On the market
Flexible Karman Cannula, size 6mm	Flexible Karman Cannula, size 6mm	`FC6`	`00853615006055`	1	On the market
Flexible Karman Cannula, size 7mm	Flexible Karman Cannula, size 7mm	`FC7`	`00853615006062`	1	On the market
Flexible Karman Cannula, size 8mm	Flexible Karman Cannula, size 8mm	`FC8`	`00853615006079`	1	On the market
Flexible Karman Cannula, size 9mm	Flexible Karman Cannula, size 9mm	`FC9`	`00853615006086`	1	On the market
Ipas EasyGrip® Cannula, size 10mm	Ipas EasyGrip® Cannula, size 10mm	`SR10`	`00853615006093`	1	On the market
Ipas EasyGrip® Cannula, size 10mm, Single-Use	Ipas EasyGrip® Cannula, size 10mm, Single-Use	`SR10-SU`	`00853615006109`	1	On the market
Ipas EasyGrip® Cannula, size 12mm	Ipas EasyGrip® Cannula, size 12mm	`SR12`	`00853615006116`	1	On the market
Ipas EasyGrip® Cannula, size 12mm, Single-Use	Ipas EasyGrip® Cannula, size 12mm, Single-Use	`SR12-SU`	`00853615006123`	1	On the market
Ipas EasyGrip® Cannula, size 4mm	Ipas EasyGrip® Cannula, size 4mm	`SR4`	`00853615006130`	1	On the market
Ipas EasyGrip® Cannula, size 4mm, Single-Use	Ipas EasyGrip® Cannula, size 4mm, Single-Use	`SR4-SU`	`00853615006147`	1	On the market
Ipas EasyGrip® Cannula, size 5mm	Ipas EasyGrip® Cannula, size 5mm	`SR5`	`00853615006154`	1	On the market
Ipas EasyGrip® Cannula, size 5mm, Single-Use	Ipas EasyGrip® Cannula, size 5mm, Single-Use	`SR5-SU`	`00853615006161`	1	On the market
Ipas EasyGrip® Cannula, size 6mm	Ipas EasyGrip® Cannula, size 6mm	`SR6`	`00853615006178`	1	On the market
Ipas EasyGrip® Cannula, size 6mm, Single-Use	Ipas EasyGrip® Cannula, size 6mm, Single-Use	`SR6-SU`	`00853615006185`	1	On the market
Ipas EasyGrip® Cannula, size 7mm	Ipas EasyGrip® Cannula, size 7mm	`SR7`	`00853615006192`	1	On the market

WomanCare Global, LLC

About WomanCare Global

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About WomanCare Global

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Export the 36 devices of WomanCare Global

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Device catalog for WomanCare Global

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Connected operators

Importers

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Market presence of WomanCare Global

Devices by risk class

Certificate health for WomanCare Global

Statistics for WomanCare Global

Device families (Basic UDI-DI) of WomanCare Global

Device catalog for WomanCare Global