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Gulden Ophthalmics

United States·US-MF-000008608

Last updated September 17, 2026

About

Over 80 years of experience have earned Gulden Ophthalmics a place as an undisputed thought leader and respected industry expert in ophthalmic instruments and devices.

From the manufacturer's own website. Source

Information

Country: United States
Address: 225, Cadwalader Avenue, Elkins Park, United States
Website: www.guldenophthalmics.com
LinkedIn: linkedin.com/company/gulden-ophthalmics
Facebook: facebook.com/pages/category/Company/Gulden-Ophthalmics-335150849939078
Email: [email protected]
Phone: 215-884-8105
PRRC Contact: Steven McLaughlin
EUDAMED SRN: US-MF-000008608
FDA FEI Number: 2518410
DUNS Number: —

Catalogue (222)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
Magnetic Prism - 45 Diopter	11201-45	EUDAMED	Class I	Active
Magnetic Prism - 50 Diopter	11201-50	EUDAMED	Class I	Active
Lens Holder Kit 8 Well	15145	EUDAMED	Class I	Active
Single Prism - 10 Diopter	11101-10	EUDAMED	Class I	Active
Red & Green Black Frame Glasses (6pk)	15320	EUDAMED	Class I	Active
Red & Green Spectacles	15105	EUDAMED	Class I	Active
Stick Prism - 45 Diopter	11104-45	EUDAMED	Class I	Active
Lens Holder without Scale	15142	EUDAMED	Class I	Active
Lanthony Desaturated D-15	15127	EUDAMED	Class I	Active
S-22 Magnetic Stick Prism Set	11L23	EUDAMED	Class I	Active
Combination Horizontal / Vertical Prism Bar	11313	EUDAMED	Class I	Active
Magnetic Stick Prism - 50 Diopter	11204-50	EUDAMED	Class I	Active
Magnetic Stick Prism - 3 Diopter	11204-3	EUDAMED	Class I	Active
Stick Prism - 5 Diopter	11104-5	EUDAMED	Class I	Active
Maddox Short	12114	EUDAMED	Class I	Active
Magnetic Stick Prism - 4 Diopter	11204-4	EUDAMED	Class I	Active
SS-8 Prism Set	11318	EUDAMED	Class I	Active
Single Prism - 14 Diopter	11101-14	EUDAMED	Class I	Active
Stick Prism - 2 Diopter	11104-2	EUDAMED	Class I	Active
Magnetic Stick Prism - 35 Diopter	11204-35	EUDAMED	Class I	Active
Stick Prism - 1 Diopter	11104-1	EUDAMED	Class I	Active
Single Prism - 8 Diopter	11101-8	EUDAMED	Class I	Active
Single Prism - 2 Diopter	11101-2	EUDAMED	Class I	Active
C-Daylight Glasses	15115	EUDAMED	Class I	Active
Occluder & Red Lens	12121	EUDAMED	Class I	Active
Single Prism - 9 Diopter	11101-9	EUDAMED	Class I	Active
B-16 Horizontal Prism Bar	11116	EUDAMED	Class I	Active
Magnetic Stick Prism - 16 Diopter	11204-16	EUDAMED	Class I	Active
Multiple Pinhole Occluder	12130	EUDAMED	Class I	Active
Flashing Fixation Sticks (2pk)	15325	EUDAMED	Class I	Active
Lens Holder Nose Bridge	15141	EUDAMED	Class I	Active
Compact Magnetic Farnsworth Dichotomous D-15	15106	EUDAMED	Class I	Active
Magnetic Prism - 5 Diopter	11201-5	EUDAMED	Class I	Active
Magnetic Stick Prism - 2 Diopter	11204-2	EUDAMED	Class I	Active
Magnetic Stick Prism - 14 Diopter	11204-14	EUDAMED	Class I	Active
S-22 Universal Prism Set	11323	EUDAMED	Class I	Active
Spielmann Occluder	12120	EUDAMED	Class I	Active
Magnetic Prism - 30 Diopter	11201-30	EUDAMED	Class I	Active
Single Prism - 15 Diopter	11101-15	EUDAMED	Class I	Active
Magnetic Prism - 3 Diopter	11201-3	EUDAMED	Class I	Active
Single Prism - 18 Diopter	11101-18	EUDAMED	Class I	Active
Double Maddox	12124	EUDAMED	Class I	Active
BV-15 Vertical Prism Bar	11117	EUDAMED	Class I	Active
Magnetic Stick Prism - 12	11204-12	EUDAMED	Class I	Active
Single Prism - 12 Diopter	11101-12	EUDAMED	Class I	Active
Stick Prism - 15 Diopter	11104-15	EUDAMED	Class I	Active
Magnetic Vergence Facility Prism	11207	EUDAMED	Class I	Active
Magnetic Prism - 35 Diopter	11201-35	EUDAMED	Class I	Active
Raff Level Trial Flipper	15156	EUDAMED	Class I	Active
B-12 Prism Bar	11113	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 29, 2002	Z-0531-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0538-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0534-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0537-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0533-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0535-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0530-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0536-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0528-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0539-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0529-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0532-03	—	terminated	lack of sterility assurance
Nov 29, 2002	Z-0540-03	—	terminated	lack of sterility assurance