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Ergostyle FX

EUDAMEDFDA UDI

Class I (EU MDR)

Ref ES5823

by Pivotal Health Solutions

Identity

Trade Name
Ergostyle FX EUDAMEDFDA UDI
Generic Name
Traction table, line-powered FDA UDI
Device Name
Powered Tables EUDAMED
Model / Reference
ES5823 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00850008449741 EUDAMEDFDA UDI
Basic UDI-DI
0850008449PoweredNQ EUDAMED
Direct Marketing DI
00850008449741 EUDAMED
FDA Product Code
INQ FDA UDI
EMDN Code
V080603 TREATMENT, DIAGNOSIS AND MONITORING MEDICAL BEDS EUDAMED
GMDN Term
Traction table, line-powered FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
890.3760 FDA UDI
Market of Registration
France 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Ergostyle FX is a cutting-edge medical device that utilizes an endocrine disruptor technology to provide effective treatment for various medical conditions. Powered tables designed for easy use and maneuverability, making it ideal for healthcare professionals and patients alike. With its advanced features and robust design, Ergostyle FX is the go-to solution for those seeking a reliable and efficient treatment option.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pivotal Health Solutions
EUDAMED SRN
US-MF-000042753
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 1367550e-acc9-4c27-a6dd-c5e4b3f61c5e 61 fields · synced Oct 6, 2026
  • FDA UDI bacfcf7a-a430-4ce4-87cc-6d36831a3629 32 fields · synced May 30, 2026