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By-Gl-1(e)

EUDAMED

Class IIa (EU MDR)

Ref BY-GL-1(E)Model BY-GL-A-1,BY-GL-C-1,BY-GL-1(A),BY-GL-1(B),BY-GL-1(C),BY-GL-1(D),BY-GL-1(E), BY-GL-1(F),BY-GL-A-1(A),BY-GL-A-2,BY-GL-A-2(A),BY-GL-A-3,BY-GL-A-3(A),BY-GL-A-4,BY-GL-A-4(A),BY-GL-A-5,BY-GL-A-5(A),BY-GL-C-1(A),BY-GL-C-2,BY-GL-C-2(A),BY-GL-E-1

by Ningbo Boya Medical Equipment Co., Ltd

Identity

Model / Reference
BY-GL-A-1,BY-GL-C-1,BY-GL-1(A),BY-GL-1(B),BY-GL-1(C),BY-GL-1(D),BY-GL-1(E), BY-GL-1(F),BY-GL-A-1(A),BY-GL-A-2,BY-GL-A-2(A),BY-GL-A-3,BY-GL-A-3(A),BY-GL-A-4,BY-GL-A-4(A),BY-GL-A-5,BY-GL-A-5(A),BY-GL-C-1(A),BY-GL-C-2,BY-GL-C-2(A),BY-GL-E-1 EUDAMED
BY-GL-1(E) EUDAMED

Identifiers

Primary DI / UDI-DI
06951467492058 EUDAMED
Basic UDI-DI
69514674130001WM EUDAMED
EMDN Code
R02010199 STANDARD BREATHING CIRCUITS - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Greece 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

By-Gl-1(e) by Ningbo Boya Medical Equipment 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

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Manufacturer

Manufacturer
Ningbo Boya Medical Equipment Co., Ltd
EUDAMED SRN
CN-MF-000032282
Authorised Representative
Caretechion GmbH DE-AR-000005946

Sources (1)

  • EUDAMED 46402fdd-a5b5-400e-a2e0-853a2588ee12 61 fields · synced Oct 6, 2026