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Medial Ultrasound Gel

EUDAMED

Class I (EU MDR)

Ref 5kg SnwiRef 5kg HospitalarRef 250g SigmaRef 5kg Healthease

by Shanghai Shenfeng Medical&Health Articles Co., Ltd

Identity

Trade Name
Medial Ultrasound Gel EUDAMED
Device Name
Medical Ultrasound Gel EUDAMED
Model / Reference
5kg Snwi EUDAMED
5kg Hospitalar EUDAMED
250g Sigma EUDAMED
5kg Healthease EUDAMED

Identifiers

Primary DI / UDI-DI
06950689130359 EUDAMED
06950689130380 EUDAMED
06950689130366 EUDAMED
06950689130229 EUDAMED
Basic UDI-DI
69506891GEL002LX EUDAMED
EMDN Code
Z12010885 INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Croatia EUDAMED
Czechia EUDAMED
Denmark EUDAMED
Belgium EUDAMED

Clinical & Handling

Sterile

No

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

Medial Ultrasound Gel by Shanghai Shenfeng Medical&Health Articles Co., Ltd — Class I — 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

Manufacturer
Shanghai Shenfeng Medical&Health Articles Co., Ltd
EUDAMED SRN
CN-MF-000012676
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED 853eb877-805e-493e-b9d1-5024843a0ad1 61 fields · synced Oct 6, 2026
  • EUDAMED 9e366629-11f8-471a-806e-0d57bcfaf9ce 61 fields · synced May 16, 2026
  • EUDAMED 4d2edef4-e1cb-4a9f-a1dc-179d704c61f4 61 fields · synced May 17, 2026
  • EUDAMED bb9a0e33-a8a0-4a6e-9986-78bc2a6a4b64 61 fields · synced May 18, 2026