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PD-L1(E1L3N) Antibody Kit(IHC)

EUDAMED

Class IVD General (EU MDR)

Ref EU008A01Model 30 tests /kit

by MEDx (Suzhou) Translational Medicine Co., Ltd.

Identity

Device Name
PD-L1(E1L3N) Antibody Kit(IHC) EUDAMED
Model / Reference
30 tests /kit EUDAMED
EU008A01 EUDAMED

Identifiers

Primary DI / UDI-DI
06975296640534 EUDAMED
Basic UDI-DI
B-06975296640534 EUDAMED
EMDN Code
W01030711 IMMUNOHISTOLOGY KITS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

Yes

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

PD-L1(E1L3N) Antibody Kit(IHC) by MEDx (Suzhou) Translational Medicine Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
MEDx (Suzhou) Translational Medicine Co., Ltd.
EUDAMED SRN
CN-MF-000028603
Authorised Representative
Kingsmead Service B.V. NL-AR-000002066

Sources (1)

  • EUDAMED 6b8a2fc5-810c-4f86-b1c9-a3b180c5e477 61 fields · synced Oct 6, 2026