Sterile, Ultrasound Probe Cover Gathered on Applicator Tube with 3 Elastics, 20…

EUDAMED

Class IIa (EU MDR)

Ref 5-T4040 KIT (ITL)

by Sheathing Technologies, Inc.

Identity

Device Name: Sterile, Ultrasound Probe Cover Gathered on Applicator Tube with 3 Elastics, 20ml Sterile Gel, Bite Block, & 2 Tape Strips EUDAMED
Model / Reference: 5-T4040 KIT (ITL) EUDAMED

Identifiers

Primary DI / UDI-DI: D-5-T4040KIT(ITL)LT EUDAMED
Basic UDI-DI: B-5-T4040KIT(ITL)LT EUDAMED
EMDN Code: T030199,Z11040185 EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Italy EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Sterile, Ultrasound Probe Cover Gathered on Applicator Tube with 3 Elastics, 20… by Sheathing Technologies, Inc. — Class IIa — MDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-5-T4040KIT(ITL)LT	Class IIa	Active

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

Manufacturer

Manufacturer: Sheathing Technologies, Inc.
EUDAMED SRN: US-MF-000044559
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (1)

EUDAMED 10fa1e14-5628-4983-bf83-cf20c4aacc81 61 fields · synced Oct 7, 2026