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ENER REACH ES Footswitch

EUDAMED

Class IIb (EU MDR)

Ref OP-FSSModel OP9, Accessories: OP-BPC，OP-FSD，OP-FSS，USC

by Reach Surgical, Inc.

Identity

Trade Name
ENER REACH ES Footswitch EUDAMED
Device Name
Electrosurgical Instruments, Accessories: Electrosurgery Bipolar Converter,Ultrasonic Footswitch,Electrosurgical Footswitch, Ultrasonic Converter, EUDAMED
Model / Reference
OP9, Accessories: OP-BPC，OP-FSD，OP-FSS，USC EUDAMED
OP-FSS EUDAMED

Identifiers

Primary DI / UDI-DI
06953815803011 EUDAMED
Basic UDI-DI
69538158Y101TQ EUDAMED
EMDN Code
Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMED

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

Category: Foot-switch, electrical

ENER REACH ES Footswitch by Reach Surgical, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Foot-switch, electrical.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Reach Surgical, Inc.
EUDAMED SRN
CN-MF-000011148
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (1)

  • EUDAMED 0d9fecd7-8055-4ca0-86b1-048e55abfad2 61 fields · synced Jun 19, 2026