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Jenx

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref JB01

by Jenx Limited

Identity

Trade Name
Small Back Pad EUDAMED
Jenx FDA UDI
Generic Name
Wheelchair/chair/stander occupant restraint/support FDA UDI
Device Name
Accessories EUDAMED
Small Back Pad FDA UDI
Model / Reference
JB01 EUDAMEDFDA UDI
Description
Small Back Pad FDA UDI

Identifiers

Primary DI / UDI-DI
05056235205302 EUDAMEDFDA UDI
Basic UDI-DI
50562352POSTURESYSACC4F EUDAMED
FDA Product Code
INN FDA UDI
EMDN Code
Y180980 SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES EUDAMED
GMDN Term
Wheelchair/chair/stander occupant restraint/support FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
890.3100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

Yes

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

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Wheelchair/chair/stander occupant restraint/support

Jenx by Jenx Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Wheelchair/chair/stander occupant restraint/support.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jenx Limited

Sources (2)

  • FDA UDI 44264c7e-ed6c-41a0-af2e-e86afa037b55 33 fields · synced Jul 12, 2026
  • EUDAMED 73cc203a-8bd0-4a08-9f43-e84c5a993708 61 fields · synced Jul 12, 2026