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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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31.07.2026 19:58

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132 device results listed.

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ASAHI Gaia Next 3

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327116848
Basic UDI-DI: 4547327DGW001NX
Reference: AH14R021P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1201 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:21

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Gaia Next 1

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327137881
Basic UDI-DI: 4547327DGW001NX
Reference: AH14R319P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1201 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Gaia Next 2

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327137898
Basic UDI-DI: 4547327DGW001NX
Reference: AH14R320P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1201 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Gaia Next 3

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327137904
Basic UDI-DI: 4547327DGW001NX
Reference: AH14R321P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1201 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Gaia Next 1

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327138918
Basic UDI-DI: 4547327DGW001NX
Reference: AH14R219P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1201 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Gaia Next 2

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327138925
Basic UDI-DI: 4547327DGW001NX
Reference: AH14R220P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1201 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Gaia Next 3

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327138932
Basic UDI-DI: 4547327DGW001NX
Reference: AH14R221P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1201 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Miracle Neo 3

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327139847
Basic UDI-DI: 4547327DGW003P3
Reference: AH14R312P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1501 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Miracle Neo 3

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327139854
Basic UDI-DI: 4547327DGW003P3
Reference: AH14R212P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1501 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

MIRACLEbros 3

Class IIINot specifiedOn the marketCMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141093
Basic UDI-DI: 4547327BGW007NH
Reference: AG14M250
EMDN: C04010202
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C2611 · Rev. １
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Miracle 6

Class IIINot specifiedOn the marketCMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141109
Basic UDI-DI: 4547327BGW007NH
Reference: AG14M260
EMDN: C04010202
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C2611 · Rev. １
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

MIRACLEbros 6

Class IIINot specifiedOn the marketCMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141116
Basic UDI-DI: 4547327BGW007NH
Reference: AG14M260
EMDN: C04010202
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C2611 · Rev. １
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Miracle 12

Class IIINot specifiedOn the marketCMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141123
Basic UDI-DI: 4547327BGW007NH
Reference: AG14M270
EMDN: C04010202
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C2611 · Rev. １
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

MIRACLEbros 12

Class IIINot specifiedOn the marketCMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141130
Basic UDI-DI: 4547327BGW007NH
Reference: AG14M270
EMDN: C04010202
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C2611 · Rev. １
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ASAHI Miracle 12

Class IIINot specifiedOn the marketCMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141147
Basic UDI-DI: 4547327BGW007NH
Reference: AG14M370
EMDN: C04010202
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C2611 · Rev. １
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Fielder

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141192
Basic UDI-DI: 4547327DGW002NZ
Reference: AGP140300J
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1311 · Rev. ２
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Fielder FC

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141208
Basic UDI-DI: 4547327DGW002NZ
Reference: AGP140201
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1311 · Rev. ２
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Fielder XT

Class IIIMDR 2017/745On the marketWell-established tech (possible)CMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141215
Basic UDI-DI: 4547327DGW002NZ
Reference: AGP140202
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C1311 · Rev. ２
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

SION

Class IIINot specifiedOn the marketCMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327144254
Basic UDI-DI: 4547327BGW011N8
Reference: AHW14R201J
EMDN: C04010201
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C2411 · Rev. 1-01
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

SION

Class IIINot specifiedOn the marketCMR substanceSingle useSterile

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327144261
Basic UDI-DI: 4547327BGW011N8
Reference: AHW14R201P
EMDN: C04010201
EMDN description: INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC
First on market country: -
Safety summary (SSCP/SSP): AMM-C2411 · Rev. 1-01
Authorised representative: Emergo Europe B.V.
Last updated: 07.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details