EUDAMED update: Aug 7, 2026

embecta Medical II LLC

US-MF-000044225

Active19 devices

Address: Kimball Drive, 300 07054 New Jersey
Role: Manufacturer
Date of registration: Sep 12, 2024
Country: United States

embecta Medical II LLC is a medical device manufacturer registered in EUDAMED. The company has 19 devices on the EU market across 17 countries. Headquartered in New Jersey, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About embecta

: US-MF-000044225
Role: Manufacturer
Country: United States
Organization name: embecta Medical II LLC
EU VAT number: Not applicable
EORI: No EORI
Trade register: 118538720
Date of registration: Sep 12, 2024

Contact details for embecta

Phone: +1-862-401-0000
Email: customercare@embecta.com
Website: https://www.embecta.com
Address: 300, KIMBALL DRIVE PARSIPPANY 07054 NEW JERSEY UNITED STATES

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Competent authority

Name: Health Products Regulatory Authority, Medical Devices Department

Phone: +353 1 676 4971
Email: devices@hpra.ie

Officers and regulatory representatives of embecta

WEI Guobao
Ensuring that the responsibilities of Article 15 (3) of Regulation (EU) 2017/745 of the European parliament and of the Council of 5 April 2017, as amended by Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023, are fulfilled.
Hidden
GRANT Nicole
Ensuring that the responsibilities of Article 15 (3) of Regulation (EU) 2017/745 of the European parliament and of the Council of 5 April 2017, as amended by Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023, are fulfilled.
Hidden

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
AutoShield Duo Safety Pen Needles	AutoShield Duo Safety Pen Needles	`329605`	`00383017960537`	100	On the market
AutoShield Duo Safety Pen Needles	AutoShield Duo Safety Pen Needles	`329535`	`00383017953539`	100	On the market
AutoShield Duo Safety Pen Needles	AutoShield Duo Safety Pen Needles	`329608`	`00383017960834`	100	On the market
embecta Pen Needles	embecta Pen Needles	`321133`	`00383017113339`	100	On the market
embecta Pen Needles	embecta Pen Needles	`321137`	`00383017113735`	100	On the market
Micro-Fine Pen Needles	Micro-Fine Pen Needles	`329479`	`00383017947934`	5	On the market
Micro-Fine Pen Needles	Micro-Fine Pen Needles	`329478`	`00383017947835`	5	On the market
Micro-Fine Ultra Pen Needles	Micro-Fine Ultra Pen Needles	`325118`	`00383017511838`	100	On the market
SafeAssist Safety Pen Needles	SafeAssist Safety Pen Needles	`329917`	`00383017991739`	100	On the market
SafeAssist Safety Pen Needles	SafeAssist Safety Pen Needles	`329916`	`00383017991630`	100	On the market
Ultra-Fine Pen Needles	Ultra-Fine Pen Needles	`329477`	`00383017947736`	5	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`305930`	`30383017593033`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`305934`	`30383017593439`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`305932`	`30383017593231`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`305935`	`30383017593538`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`328447`	`30383017844739`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`305937`	`30383017593736`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`328446`	`30383017844630`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`328449`	`30383017844937`	100	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
AutoShield Duo Safety Pen Needles	AutoShield Duo Safety Pen Needles	`329605`	`00383017960537`	100	On the market
AutoShield Duo Safety Pen Needles	AutoShield Duo Safety Pen Needles	`329535`	`00383017953539`	100	On the market
AutoShield Duo Safety Pen Needles	AutoShield Duo Safety Pen Needles	`329608`	`00383017960834`	100	On the market
embecta Pen Needles	embecta Pen Needles	`321133`	`00383017113339`	100	On the market
embecta Pen Needles	embecta Pen Needles	`321137`	`00383017113735`	100	On the market
Micro-Fine Pen Needles	Micro-Fine Pen Needles	`329479`	`00383017947934`	5	On the market
Micro-Fine Pen Needles	Micro-Fine Pen Needles	`329478`	`00383017947835`	5	On the market
Micro-Fine Ultra Pen Needles	Micro-Fine Ultra Pen Needles	`325118`	`00383017511838`	100	On the market
SafeAssist Safety Pen Needles	SafeAssist Safety Pen Needles	`329917`	`00383017991739`	100	On the market
SafeAssist Safety Pen Needles	SafeAssist Safety Pen Needles	`329916`	`00383017991630`	100	On the market
Ultra-Fine Pen Needles	Ultra-Fine Pen Needles	`329477`	`00383017947736`	5	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`305930`	`30383017593033`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`305934`	`30383017593439`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`305932`	`30383017593231`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`305935`	`30383017593538`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`328447`	`30383017844739`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`305937`	`30383017593736`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`328446`	`30383017844630`	100	On the market
Ultra-Fine SAFETY Insulin Syringes	Ultra-Fine SAFETY Insulin Syringes	`328449`	`30383017844937`	100	On the market

embecta Medical II LLC

About embecta

Contact details for embecta

Export the 19 devices of embecta

Competent authority

Officers and regulatory representatives of embecta

Connected operators

Importers

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About embecta

Contact details for embecta

Export the 19 devices of embecta

Competent authority

Officers and regulatory representatives of embecta

Statistics for embecta

Certificate health for embecta

Devices by risk class

Market presence of embecta

Device catalog for embecta

Device families (Basic UDI-DI) of embecta

Connected operators

Importers

Related searches

Certificate health for embecta

Statistics for embecta

Market presence of embecta

Devices by risk class

Device families (Basic UDI-DI) of embecta

Device catalog for embecta