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Being

EUDAMED

Class IIb (EU MDR)

Ref 01.78.109Model BIN-4000A

by Being Technology Co., Ltd.

Identity

Trade Name
BEING EUDAMED
Device Name
Infant Incubator EUDAMED
Model / Reference
BIN-4000A EUDAMED
01.78.109 EUDAMED

Identifiers

Primary DI / UDI-DI
06974990910028 EUDAMED
Basic UDI-DI
B-06974990910028 EUDAMED
EMDN Code
Z1208040302 MOBILE NEONATAL INCUBATORS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

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

Being by Being Technology Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
CN-MF-000041053
Authorised Representative
phoenix Medtech GmbH DE-AR-000007996

Sources (1)

  • EUDAMED e1b62677-f99f-4606-862d-d1510194dfc3 61 fields · synced May 23, 2026