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Disposable Sampling Brush

EUDAMED

Class I (EU MDR)

Ref 8101A30Model 81XXA/BXX series; ZCY-01/02

by Jiangsu HanHeng Medical Technology Co., Ltd.

Identity

Device Name
Disposable Sampling Brush EUDAMED
Model / Reference
81XXA/BXX series; ZCY-01/02 EUDAMED
8101A30 EUDAMED

Identifiers

Primary DI / UDI-DI
06973697812895 EUDAMED
Basic UDI-DI
697369781185RV EUDAMED
EMDN Code
A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany 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

Category: General-purpose absorbent tip applicator/swab, single-use

Disposable Sampling Brush by Jiangsu HanHeng Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose absorbent tip applicator/swab, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000018784
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (1)

  • EUDAMED 8ba60ed1-1c5a-4490-8eb5-c079a781f33d 61 fields · synced Jun 18, 2026