← Back to catalogue

Manifold Kit

EUDAMED

Class IIa (EU MDR)

Ref AM0352FModel AM0250, AM0251, AM0350, AM0351, AM0351A, AM0351C, AM0351D, AM0352, AM0352A, AM0352E, AM0352G, AM0352J, AM0353, AM0352H, AM0351-G, AM0352F, AM0352F-1, AM0351F, AM0352L, AM0352M, AM0352N, AM0352P, AM0352B, AM0352C, AM0352D.

by Shanghai INT Medical Instruments Co., Ltd.

Identity

Device Name
Manifold Kit EUDAMED
Model / Reference
AM0250, AM0251, AM0350, AM0351, AM0351A, AM0351C, AM0351D, AM0352, AM0352A, AM0352E, AM0352G, AM0352J, AM0353, AM0352H, AM0351-G, AM0352F, AM0352F-1, AM0351F, AM0352L, AM0352M, AM0352N, AM0352P, AM0352B, AM0352C, AM0352D. EUDAMED
AM0352F EUDAMED

Identifiers

Primary DI / UDI-DI
06950900965418 EUDAMED
Basic UDI-DI
69509009CEMKSA 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

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

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

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

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 acdfce72-3473-4c81-98c6-6b124b2babb0 61 fields · synced Oct 5, 2026