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Single-use Hystero Videoscope

EUDAMED

Class IIa (EU MDR)

Ref SHV-S1Model SHV-S1，SHV-S2

by Scivita Medical Technology Co., Ltd.

Identity

Trade Name
Single-use Hystero Videoscope EUDAMED
Device Name
Single-use Hystero Videoscope EUDAMED
Model / Reference
SHV-S1，SHV-S2 EUDAMED
SHV-S1 EUDAMED

Identifiers

Primary DI / UDI-DI
06971381253740 EUDAMED
Basic UDI-DI
697138125030A8B EUDAMED
Direct Marketing DI
06971381253740 EUDAMED
EMDN Code
Z12020704 HYSTEROSCOPES 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: Rigid video hysteroscope

Single-use Hystero Videoscope by Scivita Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Rigid video hysteroscope.

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 236afbe4-2e60-4c61-af28-1ee7bacd28b0 61 fields · synced Jun 17, 2026