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170 device results listed.

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+B09111L1404

BV-15 & B-16 Prism Bar Case Set

Class IMDDOn the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B09111L1404
Basic UDI-DI: B-+B09111L1404
Reference: 11L14
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 01.08.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details

LIPIFLOW SYSTEM CABLE KIT

LIPIFLOW SYSTEM CABLE

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: 00810051250220
Basic UDI-DI: 859623006a005GA
Reference: 0820-5000
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 31.07.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

TEARSCIENCE ACTIVATOR CLEAR (DISPOSABLE)

LIPIFLOW SYSTEM ACTIVATORS

Class IIaMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: TearScience, Inc.
Manufacturer SRN: US-MF-000014446
UDI-DI: 00810051250060
Basic UDI-DI: 859623006a004G8
Reference: 0803-5050
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 31.07.2026 23:16

Manufacturer products Authorised representative products Authorised representative actors View details

CATALYS PRECISION LASER SYSTEM

CATALYS SYSTEM

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: AMO Manufacturing USA, LLC
Manufacturer SRN: US-MF-000023322
UDI-DI: 05050474604797
Basic UDI-DI: 5050474a000089G
Reference: CATALYS-I
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: AMO Ireland
Last updated: 31.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

VISULAS YAG III combi

Class IIbMDDNo longer on the marketActive deviceDirect marking

Manufacturer: Carl Zeiss Meditec AG
Manufacturer SRN: DE-MF-000007732
UDI-DI: 04049471091380
Basic UDI-DI: B-04049471091380
Reference: 1272-069
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 00:13

Manufacturer products View details

VISULAS YAG III

Class IIbMDDNo longer on the marketActive deviceDirect marking

Manufacturer: Carl Zeiss Meditec AG
Manufacturer SRN: DE-MF-000007732
UDI-DI: 04049471091373
Basic UDI-DI: B-04049471091373
Reference: 1272-175
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 30.07.2026 00:13

Manufacturer products View details

VISULAS combi

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Carl Zeiss Meditec AG
Manufacturer SRN: DE-MF-000007732
UDI-DI: 04049471091496
Basic UDI-DI: 4049471_VL0004_2U
Reference: 2222-003
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 23:02

Manufacturer products View details

VISULAS yag

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Carl Zeiss Meditec AG
Manufacturer SRN: DE-MF-000007732
UDI-DI: 04049471091489
Basic UDI-DI: 4049471_VL0003_2R
Reference: 2222-004
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 23:02

Manufacturer products View details

CALLISTO eye Panel PC

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Carl Zeiss Meditec AG
Manufacturer SRN: DE-MF-000007732
UDI-DI: 04049539069214
Basic UDI-DI: 4049539_00000001_A9
Reference: 6921
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 23.07.2026 22:46

Manufacturer products View details

CALLISTO eye Panel PC

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Carl Zeiss Meditec AG
Manufacturer SRN: DE-MF-000007732
UDI-DI: 04049539103512
Basic UDI-DI: 4049539_00000001_A9
Reference: 6909
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 23.07.2026 22:38

Manufacturer products View details

Valeda Light Delivery System

200001

Class IIaMDDOn the marketActive device

Manufacturer: LumiThera, Inc.
Manufacturer SRN: US-MF-000029866
UDI-DI: +B749200001030
Basic UDI-DI: B-+B749200001030
Reference: 200001-03
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

WaveLight

Ophthalmic Excimer Laser

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Alcon Laboratories, Inc.
Manufacturer SRN: US-MF-000016248
UDI-DI: 00380659982873
Basic UDI-DI: 038065GMN000165HC
Reference: 1016
EMDN: Z12120299
EMDN description: THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: Alcon Laboratories Belgium
Last updated: 15.07.2026 23:23

Manufacturer products Authorised representative products Authorised representative actors View details

LB-14 Large Vertical Prism Bar

Prism Bar

Class IMDR 2017/745On the market

Manufacturer: Gulden Ophthalmics
Manufacturer SRN: US-MF-000008608
UDI-DI: +B091111110O
Basic UDI-DI: ++B091PrismBarsE2
Reference: 11111
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

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-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