Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3039186269

FEI Number

3039186269

Entity Name

Nordic Pharma BVG

City/State/Country

Siriusdreef, NL

Establishment Address

Siriusdreef 41, 2132 WT Hoofddorp, Siriusdreef 41, NL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Nordic Pharma BV (Owner Number: 10095781)

Owner / Operator Contact Address

1205 Westlakes Drive, Suite 275, Berwyn, PA 19312, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P960011

All Registered Proprietary Names

Biolon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2026-04-28

Official Correspondent

Melissa Goodhead

US Agent Details

Melissa Goodhead Business: NORDIC PHARMA Email: melissa.goodhead_ext@nordicpharma.com Phone: (813) 9279302

Related Public Records

Same Entity

Nordic Pharma BV

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0530-2015	Abbott Medical Optics Inc (AMO)	3	Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
Z-2062-2017	Abbott Medical Optics Inc. (AMO)	3	Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Z-2063-2017	Abbott Medical Optics Inc. (AMO)	3	Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Z-2064-2017	Abbott Medical Optics Inc. (AMO)	3	Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Z-2065-2017	Abbott Medical Optics Inc. (AMO)	3	Healon 5 Pro, Part No. 10270015

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039186269. Last updated year: 2026. Please use registration number 3039186269 when referencing this establishment in official correspondence.