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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

Ophthalmoscope Set, VISIO 2000 Classic, 2.5V XENON

Ophthalmoscope

Class IMDR 2017/745On the marketActive device

Manufacturer: Medical Devices (Pvt) Ltd
Manufacturer SRN: PK-MF-000021845
UDI-DI: 08961102785375
Basic UDI-DI: 896110278OPHVIS808Y4
Reference: 808-605-25
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:29

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Ophthalmoscope Set, PRIMA Basic

Ophthalmoscope

Class IMDR 2017/745On the marketActive device

Manufacturer: Medical Devices (Pvt) Ltd
Manufacturer SRN: PK-MF-000021845
UDI-DI: 08961102783678
Basic UDI-DI: 896110278OPHS808TN
Reference: 808-808-25
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:29

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Ophthalmoscope Set, OMNI 3000 Delux, Xenon, Grey

Ophthalmoscope

Class IMDR 2017/745On the marketActive device

Manufacturer: Medical Devices (Pvt) Ltd
Manufacturer SRN: PK-MF-000021845
UDI-DI: 08961102782428
Basic UDI-DI: 896110278OPHPOC808U8
Reference: 808-456-11
EMDN: Z12120114
EMDN description: OPHTHALMOSCOPES
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 01.08.2026 00:29

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Appasamy

Appa Auto Perimeter

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Appasamy Associates Private Limited
Manufacturer SRN: IN-MF-000008423
UDI-DI: 08904343700042
Basic UDI-DI: 89043437PERIMETER/AP901RJ
Reference: AP 901 Glaufield Lite
EMDN: Z12120115
EMDN description: OPTOMETERS
First on market country: Ireland
Authorised representative: Amstermed B.V.
Last updated: 01.08.2026 00:13

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Appasamy

Appa Autoref - Keratometer

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Appasamy Associates Private Limited
Manufacturer SRN: IN-MF-000008423
UDI-DI: 08904343700035
Basic UDI-DI: 89043437AUTOREF/AARA3
Reference: AARK 1M
EMDN: Z12120113
EMDN description: OPHTHALMOMETERS
First on market country: Ireland
Authorised representative: Amstermed B.V.
Last updated: 01.08.2026 00:13

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AVAT

AVAT01

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Digital Life Line Pte Ltd
Manufacturer SRN: SG-MF-000045643
UDI-DI: 08881300527068
Basic UDI-DI: 8881300527AVAT9F
Reference: AVAT01
EMDN: Z12120119
EMDN description: OPHTHALMOLOGICAL TREATMENT UNITS
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 01.08.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

08809240011058

PRK-5000, PRK-6000, PRK-7000, PRK-8000

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: POTEC Co., Ltd.
Manufacturer SRN: KR-MF-000012281
UDI-DI: 08809240011058
Basic UDI-DI: 880924001PRKNW
Reference: PRK-5000
EMDN: Z12120199
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 01.08.2026 00:01

Manufacturer products Authorised representative products Authorised representative actors View details

View-M

VAA-2000PSE

Class IMDR 2017/745On the marketActive device

Manufacturer: View-M Technology
Manufacturer SRN: KR-MF-000010996
UDI-DI: 08800074500183
Basic UDI-DI: 88000745VAAXT
Reference: VAA-2000PS
EMDN: Z12120180
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 23:58

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View-M

VLC-1900

Class IMDR 2017/745On the marketActive device

Manufacturer: View-M Technology
Manufacturer SRN: KR-MF-000010996
UDI-DI: 08800074500008
Basic UDI-DI: 88000745VLCYY
Reference: VLC-1900
EMDN: Z12120180
EMDN description: OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 23:58

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08720892364722

SONDA

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Reyedar B.V.
Manufacturer SRN: NL-MF-000040158
UDI-DI: 08720892364722
Basic UDI-DI: 87208923647SONDAFQ
Reference: SONDA
EMDN: Z1212012092
EMDN description: INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:54

Manufacturer products View details

08719214223632

Phacoemulsification/ Vitrectomy System

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: VitreQ B.V.
Manufacturer SRN: NL-MF-000000424
UDI-DI: 08719214223632
Basic UDI-DI: 871921422994GQ
Reference: EQ00.R01
EMDN: Z1212020702
EMDN description: PHACO-VITRECTOMY SYSTEMS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:53

Manufacturer products View details

08719214223557

Sterile Viscous Fluid Injection / Extraction Tool

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: VitreQ B.V.
Manufacturer SRN: NL-MF-000000424
UDI-DI: 08719214223557
Basic UDI-DI: 871921422997GW
Reference: VF00.D01
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:53

Manufacturer products View details

08719214223489

Sterile Ophthalmic Surgical Procedure Pack

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: VitreQ B.V.
Manufacturer SRN: NL-MF-000000424
UDI-DI: 08719214223489
Basic UDI-DI: 871921422995GS
Reference: PA00.D02
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:53

Manufacturer products View details

08719214223397

Sterile Ophthalmic Cannulation Sets

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: VitreQ B.V.
Manufacturer SRN: NL-MF-000000424
UDI-DI: 08719214223397
Basic UDI-DI: 871921422998GY
Reference: ES27.D02
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:53

Manufacturer products View details

08719214223250

Sterile Vitrectomy Probes

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: VitreQ B.V.
Manufacturer SRN: NL-MF-000000424
UDI-DI: 08719214223250
Basic UDI-DI: 871921422999H2
Reference: VT23.D01
EMDN: Z1212020703
EMDN description: VITRECTOMES
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:53

Manufacturer products View details

08719214222093

Sterile Light Fibers

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: VitreQ B.V.
Manufacturer SRN: NL-MF-000000424
UDI-DI: 08719214222093
Basic UDI-DI: 871921422990GG
Reference: LF23.D01
EMDN: Z1212020785
EMDN description: PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:53

Manufacturer products View details

Horus III

Ophthalmic unit

Class IMDR 2017/745On the marketActive device

Manufacturer: MediTop BV
Manufacturer SRN: NL-MF-000010795
UDI-DI: 08718104890206
Basic UDI-DI: 871810489_OPHTHALMIC_F8
Reference: 3500000-III
EMDN: Z12129001
EMDN description: OPHTHALMOLOGICAL INSTRUMENT STANDS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:43

Manufacturer products 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