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Disposable Hemodialysis Catheter Kit

EUDAMED

Class III (EU MDR)

Ref TGHCBSJ2-12-13DModel TGHCBSJ2-115-20,TGHCBSJ2-12-13,TGHCBSJ2-12-16,TGHCBSJ2-12-20,TGHCBSJ2-115-13D,TGHCBSJ2-115-16D,TGHCBSJ2-115-20D,TGHCBSJ2-12-13D,TGHCBSJ2-12-16D,TGHCBSJ2-12-20D,TGHCBSJ2-115-13,TGHCBSJ2-115-16

by Beijing Target Medical Technologies Inc.

Identity

Device Name
Disposable Hemodialysis Catheter Kit EUDAMED
Model / Reference
TGHCBSJ2-115-20,TGHCBSJ2-12-13,TGHCBSJ2-12-16,TGHCBSJ2-12-20,TGHCBSJ2-115-13D,TGHCBSJ2-115-16D,TGHCBSJ2-115-20D,TGHCBSJ2-12-13D,TGHCBSJ2-12-16D,TGHCBSJ2-12-20D,TGHCBSJ2-115-13,TGHCBSJ2-115-16 EUDAMED
TGHCBSJ2-12-13D EUDAMED

Identifiers

Primary DI / UDI-DI
06933272240260 EUDAMED
Basic UDI-DI
69332722MM0006D4 EUDAMED
EMDN Code
F900201 TEMPORARY HEMODIALYSIS CATHETERS AND KITS EUDAMED

Classification

Device Class
Class III EUDAMED
Market of Registration
Czechia 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

Disposable Hemodialysis Catheter Kit by Beijing Target Medical Technologies Inc. — Class III — 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

EUDAMED SRN
CN-MF-000022386
Authorised Representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Sources (1)

  • EUDAMED c11f7e87-79c7-4750-96eb-42ecf2e6f1c6 61 fields · synced Jun 18, 2026