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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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Fielder

PCI Guide Wire

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

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141185
Basic UDI-DI: 4547327DGW002NZ
Reference: AGP140200
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Austria
Safety summary (SSCP/SSP): AMM-C1311 · Rev. ２
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:25

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

ULTIMATEbros 3

PCI Guide Wire Rinato / PCI Guide Wire PROWATER, PCI Guide Wire Route / PCI Guide Wire PROWATERflex,　PCI Guide Wire ULTIMATEbros 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: 04547327141178
Basic UDI-DI: 4547327DGW004P5
Reference: AHW14S203S
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Austria
Safety summary (SSCP/SSP): AMM-C1411 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:25

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

ASAHI Miracle 3

Grand Slam PCI Guide Wire, ASAHI Miracle 3 PCI Guide Wire, MIRACLEbros 3 PCI Guide Wire, ASAHI Miracle 6 PCI Guide Wire, MIRACLEbros 6 PCI Guide Wire, ASAHI Miracle 12 PCI Guide Wire, MIRACLEbros 12 PCI Guide Wire

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

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327141086
Basic UDI-DI: 4547327BGW007NH
Reference: AG14M250
EMDN: C04010202
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Austria
Safety summary (SSCP/SSP): AMM-C2611 · Rev. １
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:25

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

ASAHI Miracle Neo 3

ASAHI Miracle Neo 3 PCI Guide Wire

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

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327139830
Basic UDI-DI: 4547327DGW003P3
Reference: AH14R012P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Austria
Safety summary (SSCP/SSP): AMM-C1501 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:25

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

ASAHI Gaia Next 1

ASAHI Gaia Next

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

Manufacturer: ASAHI INTECC CO., LTD.
Manufacturer SRN: JP-MF-000010199
UDI-DI: 04547327116824
Basic UDI-DI: 4547327DGW001NX
Reference: AH14R019P
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Austria
Safety summary (SSCP/SSP): AMM-C1201 · Rev. 2
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:25

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

Stretch™

Stretch

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729887775
Basic UDI-DI: 01915060000000000000438ND
Reference: H7493930800
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

Stingray™

Stingray Extension Wire

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729837480
Basic UDI-DI: 01915060000000000000195NA
Reference: H749M3010B0
EMDN: C04010299
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES - OTHER
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-47005637A9

Guidewire SFC-190-014/LS/medium

Class IIIMDDOn the marketWell-established tech (possible)Single useSterile

Manufacturer: EPflex Feinwerktechnik GmbH
Manufacturer SRN: DE-MF-000005425
UDI-DI: D-47005637A9
Basic UDI-DI: B-47005637A9
Reference: 47005637
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:54

Manufacturer products View details

D-460120688T

Guidewire SFCH-190-014/LS/cone-soft

Class IIIMDDOn the marketWell-established tech (possible)Single useSterile

Manufacturer: EPflex Feinwerktechnik GmbH
Manufacturer SRN: DE-MF-000005425
UDI-DI: D-460120688T
Basic UDI-DI: B-460120688T
Reference: 46012068
EMDN: C04010201
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:51

Manufacturer products View details

D-410103285T

Guidewire J3-FC-260-035/FS

Class IIIMDDOn the marketWell-established tech (possible)Single useSterile

Manufacturer: EPflex Feinwerktechnik GmbH
Manufacturer SRN: DE-MF-000005425
UDI-DI: D-410103285T
Basic UDI-DI: B-410103285T
Reference: 410102328
EMDN: C04010202
EMDN description: CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 19:08

Manufacturer products View details

ASAHI Miracle 12