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Hysteroscope

EUDAMED

Class IIa (EU MDR)

Ref J0100ARModel XG-5/XG-5A/ZG-1Ref J0100ARef J0122Ref J1330EModel ZG-2/ZG-3Ref X4011SRef X4019TRef J0112Ref X4016Ref U8661Ref J0122ARef X5803Ref X4012ARef J0100FRRef J0130Ref X4015Ref J0100F

by Shenyang Shenda Endoscope Co., Ltd.

Identity

Device Name
Hysteroscope EUDAMED
Model / Reference
XG-5/XG-5A/ZG-1 EUDAMED
J0100AR EUDAMED
J0100A EUDAMED
J0122 EUDAMED
ZG-2/ZG-3 EUDAMED
J1330E EUDAMED
X4011S EUDAMED
X4019T EUDAMED
J0112 EUDAMED
X4016 EUDAMED
U8661 EUDAMED
J0122A EUDAMED
X5803 EUDAMED
X4012A EUDAMED
J0100FR EUDAMED
J0130 EUDAMED
X4015 EUDAMED
J0100F EUDAMED

Identifiers

Primary DI / UDI-DI
06971244213416 EUDAMED
06971244213393 EUDAMED
06971244213355 EUDAMED
06971244213478 EUDAMED
06971244213553 EUDAMED
06971244213607 EUDAMED
06971244213430 EUDAMED
06971244213485 EUDAMED
06971244213669 EUDAMED
06971244213362 EUDAMED
06971244213676 EUDAMED
06971244213508 EUDAMED
06971244213423 EUDAMED
06971244213447 EUDAMED
06971244213515 EUDAMED
06971244213409 EUDAMED
Basic UDI-DI
697124421GQJ0001CH EUDAMED
697124421GQJ0002CK EUDAMED
EMDN Code
Z12020704 HYSTEROSCOPES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

Hysteroscope by Shenyang Shenda Endoscope 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
Shenyang Shenda Endoscope Co., Ltd.
EUDAMED SRN
CN-MF-000030478
Authorised Representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Sources (16)

  • EUDAMED c8316b32-4604-4cb0-b0c5-2f9a20e25b5c 61 fields · synced Oct 6, 2026
  • EUDAMED a1b109af-b0a7-4da6-8648-59af94ab00a5 61 fields · synced May 16, 2026
  • EUDAMED 8966fc57-4497-4e5c-a40b-3cbeb11f4cf9 61 fields · synced May 16, 2026
  • EUDAMED e93a53b7-2141-4109-940e-8a94ff46eb24 61 fields · synced May 16, 2026
  • EUDAMED 38672843-da77-4de1-ac0b-e4e48ea27746 61 fields · synced May 16, 2026
  • EUDAMED e8cc81b7-0e22-4579-b696-81b40770d240 61 fields · synced May 17, 2026
  • EUDAMED b5b2cd45-5227-4cd5-be3a-c465d290b871 61 fields · synced May 17, 2026
  • EUDAMED a28c75b5-ce31-41c7-a1ce-b0a810e88d7a 61 fields · synced May 17, 2026
  • EUDAMED 3ef68b3f-5a73-4e4f-b2aa-2e5b27b4c295 61 fields · synced May 17, 2026
  • EUDAMED 0ac9ef7e-6fc3-4612-af62-a7620e73f7c9 61 fields · synced May 17, 2026
  • EUDAMED 5d2d98b3-945e-46a6-bf01-b900033cce6c 61 fields · synced May 17, 2026
  • EUDAMED 0d0c338c-ad59-4bcb-a20d-3b0bd63ea77a 61 fields · synced May 17, 2026
  • EUDAMED 4787cc76-d649-4d1e-8038-29b9c3dc125c 61 fields · synced May 18, 2026
  • EUDAMED e6191774-1703-4145-8a9a-8ef8ab09e154 61 fields · synced May 18, 2026
  • EUDAMED 3054ce37-0427-44b8-bf2b-cfc7318bdf4e 61 fields · synced May 18, 2026
  • EUDAMED d95baff3-a6ee-49d5-94be-24b3725a7388 61 fields · synced May 19, 2026