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Erbe 20193-071

by Erbe Elektromedizin GmbH

Ref 20193-071

Erbe 20193-071 is a device classified as Class IIb in the EU and Class II in the US made by Erbe Elektromedizin GmbH, registered in EUDAMED on 13 May 2026 (Basic UDI-DI B-04050147005136), cleared under FDA 510(k) K972269 on 9 Jul 1997 and listed in FDA GUDID since 16 Dec 2016 (UDI-DI 04050147005136), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K972269

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04050147005136 Basic UDI-DI 04050147005136UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147005136 UDI-DI Date16 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK972269 Date9 Jul 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04050147005136 registered 13 May 2026 Active
  • FDA 510(k) K972269 decided 9 Jul 1997 Active
  • FDA GUDID UDI-DI 04050147005136 listed 16 Dec 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K972269
  2. Listed FDA GUDID 04050147005136
  3. Registered EUDAMED B-04050147005136

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ERBE NESSY®Plate 70 EUDAMED
Erbe GUDID
Generic name
Electrosurgical return electrode, single-use
Device name
NESSY Plate, SU
Model / Ref / Catalog
20193-071
Primary DI / UDI-DI
04050147005136
Basic UDI-DI
B-04050147005136
510(k) Number
FDA product code
GEI
EMDN code
K02010202 Electrosurgery dual patient pads (neutral electrodes), single-use
GMDN term
Electrosurgical return electrode, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 72.000 Square centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrosurgical return electrode, single-use

Cleared under the same submission (K972269)

and 2 more cleared under K972269

Similar devices in this category

Other devices filed under ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), SINGLE-USE.

Other devices from Erbe Elektromedizin GmbH

See all devices from Erbe Elektromedizin GmbH →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)