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iReceptal® Digital Surgical Suction System Disposable Manifold with Disinfectant

EUDAMED

Class I (EU MDR)

Ref iRM301

by Amsino International Inc.

Identity

Trade Name
iReceptal® Digital Surgical Suction System Disposable Manifold with Disinfectant EUDAMED
Device Name
Disposable Manifold with Disinfectant EUDAMED
Model / Reference
iRM301 EUDAMED

Identifiers

Primary DI / UDI-DI
00704411016857 EUDAMED
Basic UDI-DI
0704411479ZQ EUDAMED
Direct Marketing DI
00704411016857 EUDAMED
EMDN Code
A06030499 INTRA-OPERATION FLUID COLLECTION DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

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

iReceptal® Digital Surgical Suction System Disposable Manifold with Disinfectant by Amsino International, Inc. — Class I — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
US-MF-000007234
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (1)

  • EUDAMED b523c244-c228-41ad-8e19-6445af6ce90d 61 fields · synced Jul 18, 2026