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Sutter 784977SGSZ

by Sutter Medizintechnik GmbH

Ref 784977SGSZ

Sutter 784977SGSZ is an open-surgery electrosurgical handpiece/electrode (EU MDR Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, cutting & coagulation & accessories) made by Sutter Medizintechnik GmbH, registered in EUDAMED on 28 May 2026 (Basic UDI-DI ++ESUMTD02700000AL) and listed in FDA GUDID since 26 Mar 2019 (UDI-DI ESUM784977SGSZ0), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++ESUMTD02700000AL Basic UDI-DI ESUM784977SGSZ0UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberESUM784977SGSZ0 UDI-DI Date26 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++ESUMTD02700000AL registered 28 May 2026 Active
  • FDA GUDID UDI-DI ESUM784977SGSZ0 listed 26 Mar 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID ESUM784977SGSZ0
  2. Registered EUDAMED ++ESUMTD02700000AL

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Sutter
Generic name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Model / Ref / Catalog
784977SGSZ
Description
Bipolar forceps SuperGliss® zhora, US 20cm, bayonet, tip 0.7 x 5.0mm 10° angled up
Primary DI / UDI-DI
ESUM784977SGSZ0
Basic UDI-DI
++ESUMTD02700000AL
Direct marketing DI
ESUM784977SGSZ0
FDA product code
GEI
EMDN code
L180401 Open electrosurgery forceps, reusable
GMDN term
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

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: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Similar devices in this category

Other devices filed under OPEN ELECTROSURGERY FORCEPS, REUSABLE.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)