Erbe

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 20193-075

by Erbe Elektromedizin GmbH

Identity

Trade Name: ERBE NESSY®Plate 70 EUDAMED
ERBE FDA UDI
Generic Name: Electrosurgical return electrode, single-use FDA UDI
Device Name: NESSY Plate, SU EUDAMED
ERBE NESSY®Plate 70 split; 72cm²; cable 3m FDA UDI
Model / Reference: 20193-075 EUDAMEDFDA UDI
Description: ERBE NESSY®Plate 70 split; 72cm²; cable 3m FDA UDI

Identifiers

Catalog Number: 20193-075 FDA UDI
Primary DI / UDI-DI: 04050147005174 EUDAMEDFDA UDI
Basic UDI-DI: B-04050147005174 EUDAMED
510(k) Number: K972269 FDA UDI
FDA Product Code: GEI FDA UDI
EMDN Code: K02010202 ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE EUDAMED
GMDN Term: Electrosurgical return electrode, single-use FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Area/Surface Area — 72.000 Square centimeter FDA UDI

Category: Electrosurgical return electrode, single-use

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

Similar devices

Also classified as Electrosurgical return electrode, single-use.

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Swaroplate — NISSHA MEDICAL TECHNOLOGIES SAS · Class II
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Cleared under the same submission

K972269 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

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Manufacturer

Manufacturer: Erbe Elektromedizin GmbH

Sources (2)

FDA UDI 40661371-7b4d-4a55-91ed-43357c22470f 38 fields · synced Jun 18, 2026
EUDAMED 369045ed-f8bf-4e46-84bf-c9a8894ee847 61 fields · synced Jun 18, 2026