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Uscope

EUDAMED

Class IIa (EU MDR)

Ref PU3033AH (Standard Deflection)Model PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A;

by Zhuhai Pusen Medical Technology Co., Ltd.

Identity

Trade Name
Uscope EUDAMED
Device Name
Single Use Flexible Video Ureteroscope; Single Use Suction Access Ureteroscope; EUDAMED
Model / Reference
PU3022, PU3022A, PU3033A, PU3033AH; PU400A, PU411A; EUDAMED
PU3033AH (Standard Deflection) EUDAMED

Identifiers

Primary DI / UDI-DI
06971176280975 EUDAMED
Basic UDI-DI
697117628ADE EUDAMED
EMDN Code
Z12020713 URETERORENOSCOPES EUDAMED

Classification

Device Class
Class IIa 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: Flexible video ureteroscope, single-use

Uscope by Zhuhai Pusen Medical Technology Co, Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video ureteroscope, single-use.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Zhuhai Pusen Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000009220
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED fb5b6f78-f8a9-4ff4-b2b9-263cfac82585 61 fields · synced Jun 17, 2026