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ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Super Power Backup 3.0cm

EUDAMED

Class III (EU MDR)

Ref HW80SP300P10000Ref HW80SP372P10000Ref HW80PB352P10000Ref HW80SP302P10000Ref HW80SP402P10000Ref HW80SP352P10000Ref HW80PB302P10000

by Asahi Intecc Co., Ltd.

Identity

Trade Name
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Super Power Backup 3.0cm EUDAMED
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Super Power Backup 3.75cm, Side Hole EUDAMED
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Power Backup 3.5cm, Side Hole EUDAMED
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Super Power Backup 3.0cm, Side Hole EUDAMED
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Super Power Backup 4.0cm, Side Hole EUDAMED
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Super Power Backup 3.5cm, Side Hole EUDAMED
ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Power Backup 3.0cm, Side Hole EUDAMED
Device Name
ASAHI Hyperion Coronary Guide Catheter EUDAMED
Model / Reference
HW80SP300P10000 EUDAMED
HW80SP372P10000 EUDAMED
HW80PB352P10000 EUDAMED
HW80SP302P10000 EUDAMED
HW80SP402P10000 EUDAMED
HW80SP352P10000 EUDAMED
HW80PB302P10000 EUDAMED

Identifiers

Primary DI / UDI-DI
04547327104227 EUDAMED
04547327104296 EUDAMED
04547327104494 EUDAMED
04547327104234 EUDAMED
04547327104319 EUDAMED
04547327104272 EUDAMED
04547327104456 EUDAMED
Basic UDI-DI
B-04547327104227 EUDAMED
B-04547327104296 EUDAMED
B-04547327104494 EUDAMED
B-04547327104234 EUDAMED
B-04547327104319 EUDAMED
B-04547327104272 EUDAMED
B-04547327104456 EUDAMED
EMDN Code
C0104010202 CARDIAC ANGIOGRAPHY GUIDE CATHETERS EUDAMED

Classification

Device Class
Class III EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

ASAHI Hyperion Coronary Guide Catheter, 100cm, 8Fr, Super Power Backup 3.0cm by Asahi Intecc Co., Ltd. — Class III — MDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
JP-MF-000010199
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (7)

  • EUDAMED bfe59c43-9ae2-4a2f-a667-4bf0f2c0cbfb 61 fields · synced Oct 6, 2026
  • EUDAMED a9555070-d639-42dd-bf04-ec6859bec59d 61 fields · synced May 17, 2026
  • EUDAMED e3260ed1-4476-48a2-8802-f3a8909ae3f3 61 fields · synced May 17, 2026
  • EUDAMED 0c74ffd2-b72e-496c-a995-d888b1a58fcf 61 fields · synced May 17, 2026
  • EUDAMED b68ea767-bf40-4c8e-b7c1-e1b31430e05d 61 fields · synced May 18, 2026
  • EUDAMED 331f7626-bb68-40aa-be85-e8cb0aa6f80a 61 fields · synced May 18, 2026
  • EUDAMED 8ca4aa71-5b3f-4eaf-82e8-1a8a7264a57f 61 fields · synced May 18, 2026