Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

MIRACLEbros 12

UDI-DI 04547327085502Basic UDI-DI 4547327BGW007NH

Class III · MDR · ASAHI INTECC CO., LTD.

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Identification

Model: —
EMDN: C04010202
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

4202096TD05

EU technical documentation assessment · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2024-11-15 · Expiry 2029-08-13

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

4202096CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-05-15 · Expiry 2028-08-25

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

ASAHI INTECC CO., LTD.

SRN JP-MF-000010199

JP · Seto

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

Related UDI-DIs

ASAHI Miracle 12 04547327141147
ASAHI Miracle 12 04547327141123
ASAHI Miracle 3 04547327077200
ASAHI Miracle 3 04547327077293
ASAHI Miracle 3 04547327141086
ASAHI Miracle 6 04547327077316
ASAHI Miracle 6 04547327141109
Grand Slam 04547327077286
MIRACLEbros 12 04547327141130
MIRACLEbros 12 04547327085410
MIRACLEbros 3 04547327141093
MIRACLEbros 6 04547327141116

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/asahi-ptca-guide-wire-miraclebros-12-300cm-5502 · UDI page: /udi/04547327085502

All devices from ASAHI INTECC CO., LTD.

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