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Multi-frequency Convex-array Ultrasound Probe

EUDAMED

Class IIa (EU MDR)

Ref C3L40AModel C3L60K, C3L60A, C3L60C, C3L60G, C3L40C, C3L40G, C6LN, C6LC, C5L40K, C6L15K, C3I40, C3I60F, C3I60, C3I40F, C3L40A, C5I20, C5I40, C5I20GRef C3L60ARef C5I40Ref C5L40KRef C3L60KRef C3I60Ref C5I20Ref C3L40GRef C3L40C

by Shantou Institute of Ultrasonic Instruments Co., Ltd.

Identity

Device Name
Multi-frequency Convex-array Ultrasound Probe EUDAMED
Model / Reference
C3L60K, C3L60A, C3L60C, C3L60G, C3L40C, C3L40G, C6LN, C6LC, C5L40K, C6L15K, C3I40, C3I60F, C3I60, C3I40F, C3L40A, C5I20, C5I40, C5I20G EUDAMED
C3L40A EUDAMED
C3L60A EUDAMED
C5I40 EUDAMED
C5L40K EUDAMED
C3L60K EUDAMED
C3I60 EUDAMED
C5I20 EUDAMED
C3L40G EUDAMED
C3L40C EUDAMED

Identifiers

Primary DI / UDI-DI
06938396490027 EUDAMED
06938396490010 EUDAMED
06938396403584 EUDAMED
06938396495060 EUDAMED
06938396490089 EUDAMED
06938396490119 EUDAMED
06938396492137 EUDAMED
06938396490072 EUDAMED
06938396490058 EUDAMED
Basic UDI-DI
693839640010042771K00005K EUDAMED
EMDN Code
Z11040299 ULTRASOUND PROBES – OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany 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

Multi-frequency Convex-array Ultrasound Probe by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000010834
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (9)

  • EUDAMED 555ab2fa-15cf-4858-ba09-b201b3dd3175 61 fields · synced Oct 7, 2026
  • EUDAMED 6f1361b3-b9b6-4aae-a925-0da5ae2160a6 61 fields · synced May 16, 2026
  • EUDAMED 8d101ca7-16a9-43eb-aa3e-af76b897cd58 61 fields · synced May 16, 2026
  • EUDAMED 33013d50-5a74-46ff-9d58-5655fc0bbfe8 61 fields · synced May 18, 2026
  • EUDAMED 531c6805-c3b7-48f7-b9e6-f34263c458c2 61 fields · synced May 18, 2026
  • EUDAMED e62d82a0-0a95-43dd-83e7-0496bc5e7c14 61 fields · synced May 18, 2026
  • EUDAMED 64a09855-eb80-42e6-a708-c01f9bcf72bb 61 fields · synced May 18, 2026
  • EUDAMED 3656a453-e761-469d-86db-094e2462bc3b 61 fields · synced May 19, 2026
  • EUDAMED aca39353-71a7-488d-9f81-3c2d1fe205e4 61 fields · synced May 19, 2026