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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Vergence Facility Prism

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091111070T
Basic UDI-DI: ++B091VergenceFacilityLR
Reference: 11107
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Single Prism - 1 Diopter

Prism

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091111010O
Basic UDI-DI: ++B091PrismsTY
Reference: 11101-1
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 15.07.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000023322000009NB

J20007K

Class IIbMDDOn the marketActive device

Manufacturer: AMO Manufacturing USA, LLC
Manufacturer SRN: US-MF-000023322
UDI-DI: D-USMF000023322000009NB
Basic UDI-DI: B-USMF000023322000009NB
Reference: J20007K
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000023322000008N9

660065AN

Class IIaMDDOn the marketSingle useSterile

Manufacturer: AMO Manufacturing USA, LLC
Manufacturer SRN: US-MF-000023322
UDI-DI: D-USMF000023322000008N9
Basic UDI-DI: B-USMF000023322000008N9
Reference: 660065AN
EMDN: Z12120285
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000023322000007N7

590106AN

Class IIaMDDOn the marketSingle useSterile

Manufacturer: AMO Manufacturing USA, LLC
Manufacturer SRN: US-MF-000023322
UDI-DI: D-USMF000023322000007N7
Basic UDI-DI: B-USMF000023322000007N7
Reference: 590106AN
EMDN: Z12120285
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - CONSUMABLES
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000046SG

MGE-1000

Class IMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000046SG
Basic UDI-DI: B-USMF000014446000046SG
Reference: REF-300000
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000019SD

CBL-2000

Class IMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000019SD
Basic UDI-DI: B-USMF000014446000019SD
Reference: REF-240150
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000018SB

CBL-2000

Class IMDDNo longer on the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000018SB
Basic UDI-DI: B-USMF000014446000018SB
Reference: REF-240130
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: -
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000014S3

LFD-1000

Class IIaMDDNo longer on the marketActive deviceSingle useSterile

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000014S3
Basic UDI-DI: B-USMF000014446000014S3
Reference: REF-221020
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: -
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000012RX

LFTP-1000

Class IIaMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000012RX
Basic UDI-DI: B-USMF000014446000012RX
Reference: REF-210039
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000011RV

LFTP-1000

Class IIaMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000011RV
Basic UDI-DI: B-USMF000014446000011RV
Reference: REF-210037
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000013RZ

LFD-1000

Class IIaMDDNo longer on the marketActive deviceSingle useSterile

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000013RZ
Basic UDI-DI: B-USMF000014446000013RZ
Reference: REF-220120
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: -
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000010RT

LFTP-1000

Class IIaMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000010RT
Basic UDI-DI: B-USMF000014446000010RT
Reference: REF-210028
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000009SA

LFTP-1000

Class IIaMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000009SA
Basic UDI-DI: B-USMF000014446000009SA
Reference: REF-210024
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000008S8

LFTP-1000

Class IIaMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000008S8
Basic UDI-DI: B-USMF000014446000008S8
Reference: REF-210023
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000007S6

LFTP-1000

Class IIaMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000007S6
Basic UDI-DI: B-USMF000014446000007S6
Reference: REF-210019
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000006S4

LFTP-1000

Class IIaMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000006S4
Basic UDI-DI: B-USMF000014446000006S4
Reference: REF-210007
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000005S2

LFTP-1000

Class IIaMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000005S2
Basic UDI-DI: B-USMF000014446000005S2
Reference: REF-210006
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000004RY

LFTP-1000

Class IIaMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000004RY
Basic UDI-DI: B-USMF000014446000004RY
Reference: REF-210005
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-USMF000014446000003RW

LFTP-1000

Class IIaMDDOn the marketActive device

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: D-USMF000014446000003RW
Basic UDI-DI: B-USMF000014446000003RW
Reference: REF-210003
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 15.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details