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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 3 of 5

Device	Model / Reference	Registries	Class	Status
Stick Prism - 10 Diopter	11104-10	EUDAMED	Class I	Active
Compact Magnetic Combined D-15	15108	EUDAMED	Class I	Active
Magnetic Prism - 25 Diopter	11201-25	EUDAMED	Class I	Active
Magnetic Prism - 18 Diopter	11201-18	EUDAMED	Class I	Active
S-16 Universal Prism Set	11317	EUDAMED	Class I	Active
Magnetic Prism - 1/2 Diopter	11201-1/2	EUDAMED	Class I	Active
Maddox & Red Lens	12125	EUDAMED	Class I	Active
Magnetic Stick Prism - 1/2 Diopter	11204-1/2	EUDAMED	Class I	Active
Farnsworth Dichotomous D-15	15126	EUDAMED	Class I	Active
LB-14 Large Vertical Prism Bar	11111	EUDAMED	Class I	Active
Lewerenz Accommodation Maddox	12137	EUDAMED	Class I	Active
Magnetic Stick Prism - 1 Diopter	11204-1	EUDAMED	Class I	Active
Slit Lamp Yellow Filter	15192	EUDAMED	Class I	Active
Red Lens Long	12115	EUDAMED	Class I	Active
Magnetic Stick Prism - 7 Diopter	11204-7	EUDAMED	Class I	Active
Red & Green Pediatric Glasses (6pk)	15321	EUDAMED	Class I	Active
Red & Green Pediatric Frame #3	19003	EUDAMED	Class I	Active
Reversed Red & Green Wrap-Around Glasses, Adult	15318	EUDAMED	Class I	Active
Single Prism - 1 Diopter	11101-1	EUDAMED	Class I	Active
Single Prism - 50 Diopter	11101-50	EUDAMED	Class I	Active
S-16 Magnetic Stick Prism Set	11L17	EUDAMED	Class I	Active
Neutral Density Bar	15118	EUDAMED	Class I	Active
Eye Shield, Child (Bulk)	14101	EUDAMED	Class I	Active
Stick Prism - 9 Diopter	11104-9	EUDAMED	Class I	Active
Vergence Facility Prism	11107	EUDAMED	Class I	Active
Multiple Pinhole Occluder Short	12132	EUDAMED	Class I	Active
Single Prism - 3 Diopter	11101-3	EUDAMED	Class I	Active
Magnetic Stick Prism - 10 Diopter	11204-10	EUDAMED	Class I	Active
Red & Green Wrap-Around Glasses, Child	15317	EUDAMED	Class I	Active
Circular Magnetic Farnsworth Dichotomous D-15	15109	EUDAMED	Class I	Active
Magnetic Stick Prism - 5 Diopter	11204-5	EUDAMED	Class I	Active
Magnetic Stick Prism - 9 Diopter	11204-9	EUDAMED	Class I	Active
BV-15 & B-16 Prism Bar Set	11314	EUDAMED	Class I	Active
Magnetic Prism - 10 Diopter	11201-10	EUDAMED	Class I	Active
Magnetic Vergence Facility Stick Prism	11208	EUDAMED	Class I	Active
Bishop Alignment Prism Set	11311	EUDAMED	Class I	Active
Single Prism - 4 Diopter	11101-4	EUDAMED	Class I	Active
Polarized Wrap-Around Glasses, Child	15199	EUDAMED	Class I	Active
Magnetic Stick Prism - 30 Diopter	11204-30	EUDAMED	Class I	Active
Single Pinhole Occluder	12129	EUDAMED	Class I	Active
Stick Prism - 30 Diopter	11104-30	EUDAMED	Class I	Active
Single Prism - 7 Diopter	11101-7	EUDAMED	Class I	Active
Eye Shield, Child (dz)	14204	EUDAMED	Class I	Active
Reversed Red & Green Wrap-Around Glasses, Child	15319	EUDAMED	Class I	Active
Lens Holder Handle	15140	EUDAMED	Class I	Active
Stick Prism - 35 Diopter	11104-35	EUDAMED	Class I	Active
Magnetic Prism - 16 Diopter	11201-16	EUDAMED	Class I	Active
Red Lens Short	12116	EUDAMED	Class I	Active
Single Prism - 25 Diopter	11104-25	EUDAMED	Class I	Active
S-4 Prism Set	11304	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

Not available yet.

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