Erbe

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 20150-103

by Erbe Elektromedizin GmbH

Identity

Trade Name: Zweiped.-Fußsch. ERBEJET®2 EUDAMED
ERBE FDA UDI
Generic Name: Foot-switch, electrical FDA UDI
Device Name: Footswitch, hydrosurgery systems EUDAMED
ERBEJET® 2 two pedal footsw. w/ReMode; AP & IP X8 Equipment FDA UDI
Model / Reference: 20150-103 EUDAMEDFDA UDI
Description: ERBEJET® 2 two pedal footsw. w/ReMode; AP & IP X8 Equipment FDA UDI

Identifiers

Catalog Number: 20150-103 FDA UDI
Primary DI / UDI-DI: 04050147018327 EUDAMEDFDA UDI
Basic UDI-DI: B-04050147018327 EUDAMED
510(k) Number: K072404 FDA UDI
K231023 FDA UDI
FDA Product Code: FQH FDA UDI
EMDN Code: Z120106 HYDRODISSECTORS EUDAMED
GMDN Term: Foot-switch, electrical FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 880.5475 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Foot-switch, electrical

Erbe by Erbe Elektromedizin GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Foot-switch, electrical.

ElectrodeCRF — Cambridge Interventional LLC · Class IIb
ElectrodeCRF — Cambridge Interventional LLC · Class IIb
Alligature-E — Alan Electronic Systems Private Limited · Class IIb
Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · U
Arthrex® — Arthrex, Inc. · Class I
CableAME — Cambridge Interventional LLC · Class IIb
CORE — Stryker Corp. · Class II
PowerPack — MICROLINE SURGICAL, INC. · Class II

Cleared under the same submission

K072404 also covers:

K231023 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Erbe Elektromedizin GmbH

Sources (2)

FDA UDI f816eeb0-5cd0-4403-852b-5f700d60cecc 37 fields · synced Jun 18, 2026
EUDAMED 7e105e27-4174-41c2-8dc9-8f4598321395 61 fields · synced Jun 18, 2026