Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002037047

FEI Number

3002037047

Entity Name

Novartis Manufacturing NV

City/State/Country

Puurs-Sint-Amands Antwerpen, BE

Establishment Address

RIJKSWEG 14, Puurs-Sint-Amands Antwerpen 2870, BE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Novartis Pharmaceuticals Corporation (Owner Number: 10028011)

Owner / Operator Contact Address

One Health Plaza, East Hanover, NJ 07936, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Viscoat, Duovisc, DiscoVisc Provisic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2019-04-29
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2019-04-29

Official Correspondent

No official correspondent registered.

US Agent Details

Karen Costa Business: Novartis Pharmaceuticals Corporation Email: karen.costa@novartis.com Phone: (862) 3083443

Related Public Records

Same Entity

Novartis Pharmaceuticals Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027031650	Novartis Pharmaceutical Manufacturing GmbH	Langkampfen Tirol, AT

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

Similar Registrations

Registration Number	Establishment Name	Location
3039186269	Nordic Pharma BVG	Siriusdreef, NL
1610287	Alcon Research, LLC	Fort Worth, TX, US
3015456951	Alcon Laboratories Belgium	Puurs-Sint-Amands Antwerpen, BE
3007093114	ANIKA THERAPEUTICS, INC.	Bedford, MA, US
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002037047. Last updated year: 2026. Please use registration number 3002037047 when referencing this establishment in official correspondence.