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Bundled Procedure Pack

BUNDLE CUSTOM OPHTHALMIC PROCEDURE PACK IIb

Class IIbMDR 2017/745On the marketSterile

Manufacturer: Servicio Integral Hospitalario, S.L.U.
Manufacturer SRN: ES-PR-000011724
UDI-DI: 08435016725135
Basic UDI-DI: 184350167bpacks01FM
Reference: 789375/GPV25
EMDN: Q021113
EMDN description: OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 07:54

Manufacturer products View details

40888277437921

Metallic eye speculum

Class IMDR 2017/745On the marketSingle use

Manufacturer: Medline International France SAS
Manufacturer SRN: FR-MF-000000676
UDI-DI: 40888277437921
Basic UDI-DI: 0888277DC174NSKN
Reference: 12-00-1180
EMDN: Q021107
EMDN description: OPHTHALMIC SURGERY RETRACTORS, SINGLE-USE
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 07:46

Manufacturer products View details

OMNI Surgical System

1-109

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Sight Sciences, Inc.
Manufacturer SRN: US-MF-000008813
UDI-DI: 00858027006532
Basic UDI-DI: 08580270061001LA
Reference: 1-109
EMDN: Q021199
EMDN description: OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details

Opti-Gard® Patient Eye Protectors

Opti-Gard Patient Eye Protectors

Class IMDR 2017/745On the marketSingle use

Manufacturer: Dupaco, Inc
Manufacturer SRN: US-MF-000003390
UDI-DI: 00850017419032
Basic UDI-DI: 0850017419OPTIGARDWE
Reference: D28200CE
EMDN: Q021199
EMDN description: OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:13

Manufacturer products Authorised representative products Authorised representative actors View details

[Sinskey II] Micro Lens Hook, angled

Manual Handled Instruments

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516107011
Basic UDI-DI: 08405161820063
Reference: 8200A
EMDN: Q021104
EMDN description: OPHTHALMIC SURGERY MANIPULATORS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

Manufacturer products Authorised representative products Authorised representative actors View details

Lasik Cannula 27g X 22mm (7/8”), formed

Lasik Cannulas

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516106809
Basic UDI-DI: 0840516199007D
Reference: 9901-9F
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

Manufacturer products Authorised representative products Authorised representative actors View details

Chamber Maintainer 27g, side port

Chamber Maintainers

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516106243
Basic UDI-DI: 0840516190005Y
Reference: 9000
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

Manufacturer products Authorised representative products Authorised representative actors View details

Lacrimal Cannula 25g, curved

Lacrimal cannulas

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516106038
Basic UDI-DI: 0840516180005R
Reference: 8000
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

Manufacturer products Authorised representative products Authorised representative actors View details

Irrigating Vectis 24g, 1 port, 5mm width

Nucleus Removal, Irrigating, Hydrodissection & Hydrodelineation

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516105673
Basic UDI-DI: 0840516170005J
Reference: 7000
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

Manufacturer products Authorised representative products Authorised representative actors View details

Capsule Polisher 21g, side port

Capsule Polishers

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516105529
Basic UDI-DI: 0840516160005B
Reference: 6000
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

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Irrigating Cystotome 30g X 16mm (5/8"), formed

Irrigating Cystotomes and Capsulorhexis Cystotomes

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516105215
Basic UDI-DI: 08405161500054
Reference: 5000AF
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

Manufacturer products Authorised representative products Authorised representative actors View details

"J" Shaped Cannula 30g X 22mm (7/8")

“J” shape Cannulas

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516105017
Basic UDI-DI: 0840516140004V
Reference: 4000
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

Manufacturer products Authorised representative products Authorised representative actors View details

Double I/A Cannula 21g/21g, side port

I/A Cannulas and Cortex Removal

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516104874
Basic UDI-DI: 0840516130004N
Reference: 3000
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

Manufacturer products Authorised representative products Authorised representative actors View details

Anterior Chamber Cannula Thin Wall 25g X 10mm bend

Anterior Chamber Cannulas Thin Wall

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516104614
Basic UDI-DI: 0840516120004F
Reference: 2003-10
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

Manufacturer products Authorised representative products Authorised representative actors View details

Arbisser A/C Manager Angled 30g

Anterior Chamber Cannulas

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516103518
Basic UDI-DI: 08405161100048
Reference: 1000A
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:01

Manufacturer products Authorised representative products Authorised representative actors View details

Peribulbar Needle [Atkinson] 27g X 32mm (1 1/4")

Anesthesia Needles

Class IIaMDR 2017/745On the marketSterile

Manufacturer: PSI/EYE-KO, Inc.
Manufacturer SRN: US-MF-000022109
UDI-DI: 00840516102146
Basic UDI-DI: 0840516100003Z
Reference: 0001F
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: Advena Limited
Last updated: 16.07.2026 05:00

Manufacturer products Authorised representative products Authorised representative actors View details

Cannula Insertion System

CANNULA, TROCAR, OPHTHALMIC

Class IIaMDR 2017/745On the marketDirect markingSingle useSterile

Manufacturer: Medical Instrument Development Laboratories, Inc.
Manufacturer SRN: US-MF-000033104
UDI-DI: 10812480010694
Basic UDI-DI: 081248001CISAG
Reference: 5500GST
EMDN: Q021199
EMDN description: OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Viscous Fluid Cannula 20g (4mm)

Sterile cannula family of medical devices - cannulae, brushes, picks and related accessories (tubing, backflush devices and injection kits) for ophthalmic use.

Class IIaMDR 2017/745On the marketAdministering medicineDirect markingSingle useSterile

Manufacturer: MedOne Surgical, Inc.
Manufacturer SRN: US-MF-000002763
UDI-DI: 00811313012006
Basic UDI-DI: 081131301MEDSURG01QY
Reference: 3200
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: Austria
Authorised representative: Advena Limited
Last updated: 16.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

Retrobulbar Atkinson Tip

Ophthalmic Cannula

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Eagle Labs, LLC
Manufacturer SRN: US-MF-000011740
UDI-DI: 00810090010625
Basic UDI-DI: 081009001CANNULAVB
Reference: 101-25
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: France
Authorised representative: IDN (INSTITUT DIETETIQUE ET NUTRITION)
Last updated: 16.07.2026 03:53

Manufacturer products Authorised representative products Authorised representative actors View details

Swiss Bi-Manual I/A System curved / 21G

SMS390S

Class IIaMDR 2017/745On the marketActive deviceDirect markingSingle useSterile

Manufacturer: Medicel AG
Manufacturer SRN: CH-MF-000016652
UDI-DI: 07630055240033
Basic UDI-DI: 076300552IA03YX
Reference: SBS105
EMDN: Q021101
EMDN description: OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE
First on market country: Germany
Authorised representative: Rudolf Riester GmbH
Last updated: 16.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details