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Public safety and clinical performance summaries under MDR Article 32 (SSCP) and IVDR Article 29 (SSP) — in one place, searchable and exportable, with compliance signals alongside.

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Anatolia Geneworks

Bosphore CMV Quantification Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018942633
Basic UDI-DI: 868001894PCRHHVCMVQT100AB
Reference: ABCMQ2
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Italy
Safety summary (SSCP/SSP): SSP-CMQ-Rev5 · Rev. 5.0
Authorised representative: -
Last updated: 30.06.2026 17:06

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Anatolia Geneworks

Bosphore CMV Quantification Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018942626
Basic UDI-DI: 868001894PCRHHVCMVQT100AB
Reference: ABCMQ1
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Italy
Safety summary (SSCP/SSP): SSP-CMQ-Rev5 · Rev. 5.0
Authorised representative: -
Last updated: 30.06.2026 17:06

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Anatolia Geneworks

Bosphore CMV Quantification Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018941032
Basic UDI-DI: 868001894PCRHHVCMVQT100AB
Reference: ABCMQ3
EMDN: W0105040205
EMDN description: CMV - NA REAGENTS
First on market country: Italy
Safety summary (SSCP/SSP): SSP-CMQ-Rev5 · Rev. 5.0
Authorised representative: -
Last updated: 30.06.2026 17:06

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Degasin® Simetikon 280 mg

Degasin 280 mg

Class IIIMDR 2017/745On the marketAnimal tissuesSingle use

Manufacturer: WALMARK, a.s.
Manufacturer SRN: CZ-MF-000007035
UDI-DI: 08596024030625
Basic UDI-DI: 8596024DEGASIN280MG2K
Reference: N/A
EMDN: G99
EMDN description: GASTROINTESTINAL DEVICES - OTHER
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP-TD01.21.280 · Rev. 002
Authorised representative: -
Last updated: 30.06.2026 16:59

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Degasin® szimetikon 280 mg

Degasin 280 mg

Class IIIMDR 2017/745On the marketAnimal tissuesSingle use

Manufacturer: WALMARK, a.s.
Manufacturer SRN: CZ-MF-000007035
UDI-DI: 08596024030113
Basic UDI-DI: 8596024DEGASIN280MG2K
Reference: N/A
EMDN: G99
EMDN description: GASTROINTESTINAL DEVICES - OTHER
First on market country: Hungary
Safety summary (SSCP/SSP): SSCP-TD01.21.280 · Rev. 002
Authorised representative: -
Last updated: 30.06.2026 16:59

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Degasin® Simetikón 280 mg

Degasin 280 mg

Class IIIMDR 2017/745On the marketAnimal tissuesSingle use

Manufacturer: WALMARK, a.s.
Manufacturer SRN: CZ-MF-000007035
UDI-DI: 08596024030069
Basic UDI-DI: 8596024DEGASIN280MG2K
Reference: N/A
EMDN: G99
EMDN description: GASTROINTESTINAL DEVICES - OTHER
First on market country: Slovakia
Safety summary (SSCP/SSP): SSCP-TD01.21.280 · Rev. 002
Authorised representative: -
Last updated: 30.06.2026 16:59

Manufacturer products View details

Degasin® szimetikon 280 mg

Degasin 280 mg

Class IIIMDR 2017/745On the marketAnimal tissuesSingle use

Manufacturer: WALMARK, a.s.
Manufacturer SRN: CZ-MF-000007035
UDI-DI: 08596024030052
Basic UDI-DI: 8596024DEGASIN280MG2K
Reference: N/A
EMDN: G99
EMDN description: GASTROINTESTINAL DEVICES - OTHER
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP-TD01.21.280 · Rev. 002
Authorised representative: -
Last updated: 30.06.2026 16:59

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VARIANT, Hlavice CoCrMo (∢12/14) 28 S

VARIANT, Modular lower extremity replacement

Class IIIMDR 2017/745On the marketCMR substanceDirect markingImplantableSingle useSterile

Manufacturer: ProSpon, spol. s r.o.
Manufacturer SRN: CZ-MF-000019992
UDI-DI: 08595565120321
Basic UDI-DI: 8592395VARIANTLE64
Reference: O01210-2800-12018
EMDN: P090804050202
EMDN description: METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP06 · Rev. rev.03
Authorised representative: -
Last updated: 30.06.2026 16:57

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Fascigel HA

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: Contipro a.s.
Manufacturer SRN: CZ-MF-000014702
UDI-DI: 08595163799028
Basic UDI-DI: 859516379900NY
Reference: 160017
EMDN: P9099
EMDN description: IMPLANTABLE PROSTHETIC DEVICES - OTHER
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP-FAS-99 · Rev. 03
Authorised representative: -
Last updated: 30.06.2026 16:56

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Sicalm HA

35 mg

Class IIIMDR 2017/745On the marketMedicinal productSingle useSterile

Manufacturer: Contipro a.s.
Manufacturer SRN: CZ-MF-000014702
UDI-DI: 08595163777019
Basic UDI-DI: 859516377700N8
Reference: 150012
EMDN: Q010399
EMDN description: SURGICAL DENTAL DEVICES - OTHER
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP-SIC-77 · Rev. 06
Authorised representative: -
Last updated: 30.06.2026 16:56

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Hyiodine 50 g

Wound gel with sodium hyaluronate and iodine complex

Class IIIMDR 2017/745On the marketDirect markingMedicinal productSterile

Manufacturer: Contipro a.s.
Manufacturer SRN: CZ-MF-000014702
UDI-DI: 08595163774506
Basic UDI-DI: 859516377400MR
Reference: N/A
EMDN: M04041503
EMDN description: DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP-HYIO-74 · Rev. 04
Authorised representative: -
Last updated: 30.06.2026 16:56

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Hyatoprol 50 g

Wound gel with sodium hyaluronate and iodine complex

Class IIIMDR 2017/745On the marketDirect markingMedicinal productSterile

Manufacturer: Contipro a.s.
Manufacturer SRN: CZ-MF-000014702
UDI-DI: 08595163774230
Basic UDI-DI: 859516377400MR
Reference: N/A
EMDN: M04041503
EMDN description: DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS
First on market country: Portugal
Safety summary (SSCP/SSP): SSCP-HYIO-74 · Rev. 04
Authorised representative: -
Last updated: 30.06.2026 16:56

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ELiS - Konos, DM - Cementless cup (Ti+HA), D10

ELIS, Type: T

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: BEZNOSKA, s.r.o.
Manufacturer SRN: CZ-MF-000000543
UDI-DI: 08592602254162
Basic UDI-DI: 859260207001FZ
Reference: 413231
EMDN: P090404
EMDN description: HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP/2022/001 · Rev. 3
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

ELiS - Konos, DM - Cementless cup (Ti+HA), D9

ELIS, Type: T

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: BEZNOSKA, s.r.o.
Manufacturer SRN: CZ-MF-000000543
UDI-DI: 08592602254155
Basic UDI-DI: 859260207001FZ
Reference: 413230
EMDN: P090404
EMDN description: HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP/2022/001 · Rev. 3
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

ELiS - Sphere, DM - Cementless cup (Ti+HA), D10

ELIS, Type: T

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: BEZNOSKA, s.r.o.
Manufacturer SRN: CZ-MF-000000543
UDI-DI: 08592602254148
Basic UDI-DI: 859260207001FZ
Reference: 413229
EMDN: P090404
EMDN description: HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP/2022/001 · Rev. 3
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

ELiS - Sphere, DM - Cementless cup (Ti+HA), D9

ELIS, Type: T

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: BEZNOSKA, s.r.o.
Manufacturer SRN: CZ-MF-000000543
UDI-DI: 08592602254131
Basic UDI-DI: 859260207001FZ
Reference: 413228
EMDN: P090404
EMDN description: HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP/2022/001 · Rev. 3
Authorised representative: -
Last updated: 30.06.2026 16:56

Manufacturer products View details

ELiS - Konos, DM - Cementless cup (Ti), D10

ELIS, Type: T

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: BEZNOSKA, s.r.o.
Manufacturer SRN: CZ-MF-000000543
UDI-DI: 08592602254124
Basic UDI-DI: 859260207001FZ
Reference: 413227
EMDN: P090404
EMDN description: HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP/2022/001 · Rev. 3
Authorised representative: -
Last updated: 30.06.2026 16:55

Manufacturer products View details

ELiS - Konos, DM - Cementless cup (Ti), D9

ELIS, Type: T

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: BEZNOSKA, s.r.o.
Manufacturer SRN: CZ-MF-000000543
UDI-DI: 08592602254117
Basic UDI-DI: 859260207001FZ
Reference: 413226
EMDN: P090404
EMDN description: HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP/2022/001 · Rev. 3
Authorised representative: -
Last updated: 30.06.2026 16:55

Manufacturer products View details

ELiS - Sphere, DM - Cementless cup (Ti), D10

ELIS, Type: T

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: BEZNOSKA, s.r.o.
Manufacturer SRN: CZ-MF-000000543
UDI-DI: 08592602254100
Basic UDI-DI: 859260207001FZ
Reference: 413225
EMDN: P090404
EMDN description: HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP/2022/001 · Rev. 3
Authorised representative: -
Last updated: 30.06.2026 16:55

Manufacturer products View details

ELiS - Sphere, DM - Cementless cup (Ti), D9

ELIS, Type: T

Class IIIMDR 2017/745On the marketImplantableSingle useSterile

Manufacturer: BEZNOSKA, s.r.o.
Manufacturer SRN: CZ-MF-000000543
UDI-DI: 08592602254094
Basic UDI-DI: 859260207001FZ
Reference: 413224
EMDN: P090404
EMDN description: HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS
First on market country: Czechia
Safety summary (SSCP/SSP): SSCP/2022/001 · Rev. 3
Authorised representative: -
Last updated: 30.06.2026 16:55

Manufacturer products View details