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Intacs® Corneal Implants

ISKS, ISK, ISKA, ICIS, ICI, ICIA

Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331791
Basic UDI-DI
84351943032SC
Reference
ISKS-210-150
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
Spain
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:42
Class IIaMDR 2017/745On the marketSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194320832
Basic UDI-DI
84351943020S5
Reference
PROCUL-L-AJL
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331807
Basic UDI-DI
84351943032SC
Reference
ISKS-250-150
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Intacs® Corneal Implants

ISKS, ISK, ISKA, ICIS, ICI, ICIA

Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331814
Basic UDI-DI
84351943032SC
Reference
ISKS-250-90
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
Spain
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331821
Basic UDI-DI
84351943032SC
Reference
ISKS-300-130
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331838
Basic UDI-DI
84351943032SC
Reference
ISKS-300-150
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331845
Basic UDI-DI
84351943032SC
Reference
ISKS-300-90
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331852
Basic UDI-DI
84351943032SC
Reference
ISKS-350-130
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331869
Basic UDI-DI
84351943032SC
Reference
ISKS-350-150
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331876
Basic UDI-DI
84351943032SC
Reference
ISKS-350-90
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331883
Basic UDI-DI
84351943032SC
Reference
ISKS-400-130
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331890
Basic UDI-DI
84351943032SC
Reference
ISKS-400-150
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331906
Basic UDI-DI
84351943032SC
Reference
ISKS-400-90
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331920
Basic UDI-DI
84351943032SC
Reference
ISKS-450-130
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331937
Basic UDI-DI
84351943032SC
Reference
ISKS-450-150
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331944
Basic UDI-DI
84351943032SC
Reference
ISKS-450-90
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194331951
Basic UDI-DI
84351943032SC
Reference
ISKS-500-150
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194335744
Basic UDI-DI
84351943032SC
Reference
ISK-210-150
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194335751
Basic UDI-DI
84351943032SC
Reference
ISK-250-150
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40
Class IIbMDR 2017/745On the marketImplantableSingle useSterile
Manufacturer
AJL OPHTHALMIC, S.A
Manufacturer SRN
ES-MF-000000267
UDI-DI
08435194335768
Basic UDI-DI
84351943032SC
Reference
ISK-300-150
EMDN
Q0299
EMDN description
OPHTHALMIC DEVICES - OTHER
First on market country
-
Safety summary (SSCP/SSP)
I-07-02-INT-IMP · Rev. 1
Authorised representative
-
Last updated
07.08.2026 21:40