Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015528193

FEI Number

3015528193

Entity Name

Almac Pharma Services (Ireland) Limited

City/State/Country

Dundalk Louth, IE

Establishment Address

Finnabair Industrial Estate, Dundalk Louth A91 P9KD, IE

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Almac Pharma Services Limited (Owner Number: 10055056)

Owner / Operator Contact Address

22 Seagoe Industrial Estate, Craigavon, GB-ABC BT63 5QD, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133635

PMA Number

N/A

All Registered Proprietary Names

Vanishpoint Easypoint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2025-06-05
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-06-05

Official Correspondent

Barry Espie

US Agent Details

Mark Rohlfing Business: Almac Clinical Services LLC Email: almacpharmausagent@almacgroup.com Phone: (215) 6608500

Related Public Records

Same Entity

Almac Pharma Services Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3000214934	ALMAC PHARMA SERVICES LLC	Audubon, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
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

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3029328631	PEGASUS IMPORTS	Houston, TX, US
3012116434	ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.	Taihu Anhui, CN
3008719222	ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd	HANGZHOU Zhejiang, CN
3036722184	CMT HEALTH PTE. LTD.	Singapore, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015528193. Last updated year: 2026. Please use registration number 3015528193 when referencing this establishment in official correspondence.