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Manifold Kit

EUDAMED

Class IIa (EU MDR)

Ref AM0350,Model AM0350,AM0351,AM0352,AM0353

by Shanghai INT Medical Instruments Co., Ltd.

Identity

Trade Name
Manifold Kit EUDAMED
Device Name
Manifold Kit EUDAMED
Model / Reference
AM0350,AM0351,AM0352,AM0353 EUDAMED
AM0350, EUDAMED

Identifiers

Primary DI / UDI-DI
D-ManifoldkitAQ EUDAMED
Basic UDI-DI
B-ManifoldkitAQ EUDAMED
EMDN Code
C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Vascular guidewire introduction sleeve

Manifold Kit by Shanghai INT Medical Instruments Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guidewire introduction sleeve.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Shanghai INT Medical Instruments Co., Ltd.
EUDAMED SRN
CN-MF-000009966
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 6505867b-88fd-4b4d-8432-7a55a0b68f2c 61 fields · synced Jun 18, 2026