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Infusion Set for Single Use, Auto-fill (De-bubble) + Auto-Stop precision filter…

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref Ins-1115Model Infusion Set for Single Use, Auto-fill (De-bubble)

by Gemtier Medical (Shanghai) Inc.

Identity

Trade Name
Infusion Set for Single Use, Auto-fill (De-bubble) + Auto-Stop precision filter + Auto-Prime cap with Injection site Protector, PVC tubing EUDAMED
Device Name
Infusion Set for Single Use EUDAMED
Model / Reference
Infusion Set for Single Use, Auto-fill (De-bubble) EUDAMED
Ins-1115 EUDAMED

Identifiers

Primary DI / UDI-DI
16955356113458 EUDAMED
Basic UDI-DI
69553561INSZBY4 EUDAMED
Direct Marketing DI
16955356113458 EUDAMED
EMDN Code
A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Italy 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

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Infusion Set for Single Use, Auto-fill (De-bubble) + Auto-Stop precision filter… by Gemtier Medical (Shanghai) Inc. — Class I — FDA_510K, MDR — listed in…

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Gemtier Medical (Shanghai) Inc.
EUDAMED SRN
CN-MF-000003835
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (2)

  • EUDAMED baae470e-df90-49e2-966f-7c4229da048c 61 fields · synced Jun 20, 2026
  • FDA 510(k) K952015 1 fields · synced May 18, 2026