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Single-use Flexible Ureteroscope

EUDAMED

Class IIa (EU MDR)

Ref SUV-3A-BModel SUV-1A-B,SUV-1A-P,SUV-2A-B,SUV-2A-P,SUV-2B-B,SUV-2B-P,SUV-2C-B,SUV-2C-P,SUV-3A-B,SUV-3C-B,SUV-4A-B,SUV-4C-B

by Scivita Medical Technology Co., Ltd.

Identity

Trade Name
Single-use Flexible Ureteroscope EUDAMED
Device Name
Single-use Flexible Ureteroscope EUDAMED
Model / Reference
SUV-1A-B,SUV-1A-P,SUV-2A-B,SUV-2A-P,SUV-2B-B,SUV-2B-P,SUV-2C-B,SUV-2C-P,SUV-3A-B,SUV-3C-B,SUV-4A-B,SUV-4C-B EUDAMED
SUV-3A-B EUDAMED

Identifiers

Primary DI / UDI-DI
06971381254808 EUDAMED
Basic UDI-DI
697138125007A8H EUDAMED
Direct Marketing DI
06971381254808 EUDAMED
EMDN Code
Z12020713 URETERORENOSCOPES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Belgium 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

Single-use Flexible Ureteroscope by Scivita 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
Scivita Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000010305
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 37b4abb5-db8b-4672-9a9e-2543bbf7fa8e 61 fields · synced May 23, 2026