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e∙Sense

FDA UDI

Class II (US FDA UDI)

by Pendracare International, B.V.

Identity

Trade Name
e∙Sense FDA UDI
Generic Name
Urodynamic catheter FDA UDI
Device Name
e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina. FDA UDI
Model / Reference
Bladder & Urethral Dual Sensor Catheter, straight tip shape FDA UDI
Description
e∙Sense Urodynamic catheters are single-use urodynamic pressure-sensing catheters and are intended to perform pressure measurement in the bladder, urethra, rectum or vagina. FDA UDI

Identifiers

Catalog Number
37042005 FDA UDI
Primary DI / UDI-DI
08718122028339 FDA UDI
FDA Product Code
FEN FDA UDI
GMDN Term
Urodynamic catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 40 Centimeter FDA UDI

Category: Urodynamic catheter

e∙Sense by Pendracare International, B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urodynamic catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pendracare International, B.V.

Sources (1)

  • FDA UDI 4aed7935-d92f-4efe-b2eb-d0b33dd76f98 36 fields · synced Jun 6, 2026