BIOMARIN INTERNATIONAL LIMITED

FDA Device Registration & Listing · Ringaskiddy Munster, IE · Registration 3010085632

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
3010085632
FEI Number
3010085632
Entity Name
BIOMARIN INTERNATIONAL LIMITED
City/State/Country
Ringaskiddy Munster, IE
Establishment Address
Shanbally, Ringaskiddy Munster P43 R298, IE
Establishment Type(s)
Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
BioMarin Pharmaceutical (Owner Number: 10054923)
Owner / Operator Contact Address
105 Digital Drive, Novato, CA 94949, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Easypoint Vanishpoint Brinuera Administration Kit

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 2025-05-06
MEG Syringe, Antistick General Hospital Class 2 880.5860 2025-05-06
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2017-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

Jocelyn Oriondo Business: BioMarin Pharmaceuticals Inc Email: jocelyn.oriondo@bmrn.com Phone: (415) 5063102

Related Public Records

Same Entity

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

Related 510(k) Records

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

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 3010085632. Last updated year: 2026. Please use registration number 3010085632 when referencing this establishment in official correspondence.
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