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Trocar

EUDAMED

Class IIa (EU MDR)

Ref OBS-T05-A,OBS-T10-A,OBS-T10-AT,OBS-T12-AT,OBS-T05-B, OBS-T10-B, OBS-T10-BT,OBS-T03-S,OBS-T05-S,OBS-T10-CT,OBS-T12-CTModel OBS-T05-A, OBS-T10-A, OBS-T10-AT, OBS-T12-AT, OBS-T05-B, OBS-T10-B, OBS-T10-BT, OBS-T03-S, OBS-T05-S, OBS-T10-CT, OBS-T12-CT

by Baisheng Medical Co., Ltd.

Identity

Trade Name
Trocar EUDAMED
Device Name
Disposable Trocar EUDAMED
Model / Reference
OBS-T05-A, OBS-T10-A, OBS-T10-AT, OBS-T12-AT, OBS-T05-B, OBS-T10-B, OBS-T10-BT, OBS-T03-S, OBS-T05-S, OBS-T10-CT, OBS-T12-CT EUDAMED
OBS-T05-A,OBS-T10-A,OBS-T10-AT,OBS-T12-AT,OBS-T05-B, OBS-T10-B, OBS-T10-BT,OBS-T03-S,OBS-T05-S,OBS-T10-CT,OBS-T12-CT EUDAMED

Identifiers

Primary DI / UDI-DI
06939411506648 EUDAMED
Basic UDI-DI
69394115OBSDTVL EUDAMED
Direct Marketing DI
06939411506648 EUDAMED
EMDN Code
K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Northern Ireland 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

Trocar by Baisheng Medical 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
Baisheng Medical Co., Ltd.
EUDAMED SRN
CN-MF-000024558
Authorised Representative
Prolinx GmbH DE-AR-000005129

Sources (2)

  • EUDAMED 648c472f-9284-487b-8f77-e7e4e3c134a5 61 fields · synced Jun 18, 2026
  • EUDAMED 648c472f-9284-487b-8f77-e7e4e3c134a5-1 61 fields · synced Jun 10, 2026