embecta Penel Limited

FDA Device Registration & Listing · Dun Laoghaire Co. Dublin, IE · Registration 3023359743

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023359743
FEI Number
3023359743
Entity Name
embecta Penel Limited
City/State/Country
Dun Laoghaire Co. Dublin, IE
Establishment Address
Pottery Road, Dun Laoghaire Co. Dublin -, IE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
embecta Corp. (Owner Number: 10084714)
Owner / Operator Contact Address
300 Kimball Drive, Parsippany, NJ 07054, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212015
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2022-10-19
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2022-10-18

Official Correspondent

Heather Reed

US Agent Details

Heather Reed Business: EMBECTA CORP. Email: regulatory.affairs@embecta.com Phone: (978) 3874086

Related Public Records

Same Entity

embecta Corp.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027605735 embecta Medical Devices (Suzhou) Co., Ltd. Suzhou Jiangsu, CN
3024508819 embecta medical I LLC Holdrege, NE, US
3022699058 Embecta Medical II LLC Parsippany, NJ, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K812404 Nu Tech Medical Systems BUTTERFLY NEEDLE ASSEMBLY 1981-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2022 Bard Peripheral Vascular Inc 2
REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023359743. Last updated year: 2026. Please use registration number 3023359743 when referencing this establishment in official correspondence.
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