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Buffer

EUDAMED

Class A (EU MDR)

Ref 06970293026978

by Zhejiang xinke Medical Technology Co., Ltd.

Identity

Device Name
Buffer EUDAMED
Model / Reference
06970293026978 EUDAMED

Identifiers

Primary DI / UDI-DI
06970293026978 EUDAMED
Basic UDI-DI
697029302buffer001R7 EUDAMED
EMDN Code
W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Buffer by Zhejiang xinke Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000032274
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (1)

  • EUDAMED d253b368-9462-4539-aa03-f630a420dbaa 61 fields · synced Jun 18, 2026