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Single-use Cystoscope

EUDAMED

Class IIa (EU MDR)

Ref PCS24-4Model PCS12-1, PCS12-2, PCS12-3, PCS22-1, PCS22-2, PCS22-3, PCS22-4, PCS22-5, PCS22-6, PCS24-1, PCS24-2, PCS24-3, PCS24-4, PCS24-5, PCS24-6

by Hunan Endoso Life Technology Co., Ltd

Identity

Device Name
Single-use Cystoscope EUDAMED
Model / Reference
PCS12-1, PCS12-2, PCS12-3, PCS22-1, PCS22-2, PCS22-3, PCS22-4, PCS22-5, PCS22-6, PCS24-1, PCS24-2, PCS24-3, PCS24-4, PCS24-5, PCS24-6 EUDAMED
PCS24-4 EUDAMED

Identifiers

Primary DI / UDI-DI
06975202773448 EUDAMED
Basic UDI-DI
697520277YS020L5 EUDAMED
Direct Marketing DI
06975202773448 EUDAMED
EMDN Code
Z12020711 VIDEO CYSTOURETHROSCOPES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Netherlands 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

Single-use Cystoscope by Hunan Endoso Life Technology Co., Ltd — Class IIa — 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-000021400
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (1)

  • EUDAMED 81e9a691-cc3a-4145-9870-425556d0d2c8 61 fields · synced Jun 18, 2026