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ultrasonic transducer

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref L15-7bRef L17-7SQRef SP5-1QRef C6-2MQRef P7-3QRef L761-2Ref L12-5HQRef MC9-3TQRef E611-2Ref SC6-1QRef L18-4XQRef C361-2Ref MC8-4QRef L1042UBRef E10-3MQRef C6152UBRef P5-1QRef E10-3HQRef L552UBRef C612UBRef L17-7QRef C5-1XQRef L12-4BQRef L742UBRef L17-7EQ

by Edan Instruments, Inc.

Identity

Trade Name
ultrasonic transducer EUDAMEDFDA UDI
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Rectal/vaginal ultrasound imaging transducer FDA UDI
Device Name
ultrasonic transducer EUDAMED
Model / Reference
L552UB EUDAMEDFDA UDI
L15-7b EUDAMEDFDA UDI
C361-2 EUDAMEDFDA UDI
L17-7SQ EUDAMEDFDA UDI
P7-3Q EUDAMEDFDA UDI
MC8-4Q EUDAMEDFDA UDI
E10-3HQ EUDAMEDFDA UDI
L761-2 EUDAMEDFDA UDI
L742UB EUDAMEDFDA UDI
C5-1XQ EUDAMEDFDA UDI
L12-5HQ EUDAMEDFDA UDI
E611-2 EUDAMEDFDA UDI
C612UB EUDAMEDFDA UDI
L17-7Q EUDAMEDFDA UDI
C6152UB EUDAMEDFDA UDI
MC9-3TQ EUDAMEDFDA UDI
L1042UB EUDAMEDFDA UDI
P5-1Q EUDAMEDFDA UDI
C6-2MQ EUDAMEDFDA UDI
SP5-1Q EUDAMED
SC6-1Q EUDAMED
L18-4XQ EUDAMED
E10-3MQ EUDAMED
L12-4BQ EUDAMED
L17-7EQ EUDAMED
L10-4D FDA UDI

Identifiers

Primary DI / UDI-DI
06944413806429 EUDAMEDFDA UDI
06944413806566 EUDAMEDFDA UDI
06944413805941 EUDAMEDFDA UDI
06944413805835 EUDAMEDFDA UDI
06944413809031 EUDAMEDFDA UDI
06944413808201 EUDAMEDFDA UDI
06944413812154 EUDAMEDFDA UDI
06944413806542 EUDAMEDFDA UDI
06944413806375 EUDAMEDFDA UDI
06944413831797 EUDAMEDFDA UDI
06944413816701 EUDAMEDFDA UDI
06944413806481 EUDAMEDFDA UDI
06944413806450 EUDAMEDFDA UDI
06944413812185 EUDAMEDFDA UDI
06944413806443 EUDAMEDFDA UDI
06944413809055 EUDAMEDFDA UDI
06944413806382 EUDAMEDFDA UDI
06944413809000 EUDAMEDFDA UDI
06944413812192 EUDAMEDFDA UDI
06944413838529 EUDAMED
06944413828995 EUDAMED
06944413837522 EUDAMED
06944413826656 EUDAMED
06944413830813 EUDAMED
06944413819764 EUDAMED
06944413806047 FDA UDI
Basic UDI-DI
69444138UTGG EUDAMED
Direct Marketing DI
06944413826656 EUDAMED
06944413812154 EUDAMED
510(k) Number
K180862 FDA UDI
K250214 FDA UDI
K192879 FDA UDI
K192791 FDA UDI
K171900 FDA UDI
FDA Product Code
ITX FDA UDI
EMDN Code
Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
Z110402010301 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL EUDAMED
Z110402010202 CURVILINEAR TRANSCUTANEOUS MULTIDIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL EUDAMED
Z1104020202 ENDOCAVITARY ULTRASOUND PROBES, MULTIDIMENSIONAL EUDAMED
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Rectal/vaginal ultrasound imaging transducer FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Market of Registration
Germany EUDAMED
Denmark EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDIFDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDIFDA UDI

Category: Extracorporeal ultrasound imaging transducer, hand-held

ultrasonic transducer by Edan Instruments, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Extracorporeal ultrasound imaging transducer, hand-held.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Edan Instruments, Inc.

Sources (45)

  • FDA UDI 54fc9915-69f4-4fed-b4d1-afa950c9da01 32 fields · synced Sep 18, 2026
  • FDA UDI 0721b192-f769-4228-bfe3-4dc489f05245 32 fields · synced May 27, 2026
  • FDA UDI 0d4e2b44-a462-4aa8-9c5b-6630b4663113 32 fields · synced May 29, 2026
  • FDA UDI a0194137-4eb4-4967-8035-da79b9dc7a8e 32 fields · synced May 29, 2026
  • FDA UDI e8b2d8bd-4183-4b65-802b-4a91809f7de2 32 fields · synced May 29, 2026
  • FDA UDI 5307255f-b34e-40bd-8228-3231d57b8c0f 33 fields · synced May 29, 2026
  • FDA UDI 9852b23b-fe1c-492d-9ea1-03adbee105ad 32 fields · synced May 30, 2026
  • FDA UDI 206da798-b3d3-49cd-8a6a-a0ac27dc8e1e 33 fields · synced May 30, 2026
  • FDA UDI e75095cc-af70-423d-9e6e-de62079c11f2 32 fields · synced May 30, 2026
  • FDA UDI eb257d53-27b7-49fd-a88d-4a48e08b1ec9 32 fields · synced May 30, 2026
  • FDA UDI a3f783e0-5670-460d-9dff-8c832b0fc84c 33 fields · synced May 30, 2026
  • FDA UDI dd47218c-a967-44f3-b3bc-4460b3116a8b 33 fields · synced May 30, 2026
  • FDA UDI 70e1265c-d8f0-48c1-9f89-b0bfeda0b83e 32 fields · synced May 30, 2026
  • FDA UDI 41dfea32-7fb6-4de8-a43b-c6b1a04521e1 32 fields · synced May 30, 2026
  • FDA UDI 96c9d4dd-6977-4d7a-9512-512f81010852 33 fields · synced May 30, 2026
  • FDA UDI 578789ca-e5bb-4847-b9fa-3caf942db90f 32 fields · synced May 30, 2026
  • FDA UDI ad2e4973-4303-4a3a-96bd-c5d27095ffbe 33 fields · synced May 30, 2026
  • FDA UDI 4806dd23-8e23-4a53-89ca-c1b888bf0a35 32 fields · synced May 30, 2026
  • FDA UDI 87456950-ddf4-4454-84e0-1ee5ffa3abef 33 fields · synced May 30, 2026
  • FDA UDI 8f7702d5-6a15-4b91-8e96-1a94231e6779 33 fields · synced May 30, 2026
  • EUDAMED ecc4958b-9752-42e8-86eb-fa0fc61fed30 61 fields · synced Jun 20, 2026
  • EUDAMED 9c10b63f-90e9-458d-a545-9e87c84d48cc 61 fields · synced Jun 20, 2026
  • EUDAMED f88fc644-668e-430f-ab4f-439878d4bd2b 61 fields · synced Jul 8, 2026
  • EUDAMED 0d021d9e-134c-4a61-9044-b8650bf93886 61 fields · synced Jul 8, 2026
  • EUDAMED 792314ae-b8ed-4fb1-bee5-e74be0799113 61 fields · synced Jul 9, 2026
  • EUDAMED 6fed769a-1302-4d69-b29f-b6907d1d70ff 61 fields · synced Jul 9, 2026
  • EUDAMED dffb75a6-1407-4c41-9336-13487bbf82e6 61 fields · synced Jul 9, 2026
  • EUDAMED fac29360-0b74-4e9b-a946-66e18c1f0945 61 fields · synced Jul 9, 2026
  • EUDAMED b4aa3e6f-6815-427a-8357-58d6dc504c39 61 fields · synced Jul 9, 2026
  • EUDAMED 1b7edb37-6f7e-4dd2-b7a9-dfb9d8f83ec5 61 fields · synced Jul 10, 2026
  • EUDAMED a90baabf-fcac-49ca-90c6-4d075123c3e0 61 fields · synced Jul 10, 2026
  • EUDAMED 4f4c9256-73ef-417c-997d-c6decf1607e8 61 fields · synced Jul 10, 2026
  • EUDAMED fcb41115-b284-49fc-b338-a22e45b77e3b 61 fields · synced Jul 10, 2026
  • EUDAMED 56586171-3453-4562-84c4-9743e2b0e9a9 61 fields · synced Jul 10, 2026
  • EUDAMED 23a06916-724b-4218-9a40-cf74252bde34 61 fields · synced Jul 14, 2026
  • EUDAMED f66f3c27-e329-4e64-ba3d-703dec5122df 61 fields · synced Jul 16, 2026
  • EUDAMED 846c8911-4411-4109-bca1-d7e265e4c98c 61 fields · synced Jul 18, 2026
  • EUDAMED 0b12915e-0098-4da1-a51a-b0df847c3be0 61 fields · synced Jul 19, 2026
  • EUDAMED 2b1fccda-d28f-4f11-8b10-5ba8ee424b6e 61 fields · synced Jul 19, 2026
  • EUDAMED f50cfc2f-0034-4410-888f-9b57aebedc6b 61 fields · synced Jul 21, 2026
  • EUDAMED 14ac9f2d-31b1-4233-a697-3732bb062918 61 fields · synced Jul 21, 2026
  • EUDAMED a4114744-6346-4dfa-a229-b398e1e622a4 61 fields · synced Jul 22, 2026
  • EUDAMED 70703b9f-1a52-48dd-972b-fb8f1ff05f16 61 fields · synced Jul 27, 2026
  • EUDAMED 3bf0faa7-a880-4a63-af2e-abdb937362f6 61 fields · synced Jul 27, 2026
  • EUDAMED c5b50866-dc26-41bd-af43-6dd15db71063 61 fields · synced Sep 18, 2026