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HYBRIDknife® flex T-Type

by Erbe Elektromedizin GmbH 2 variants

Ref 20150-111

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4050147HYBRIDknifeflex-GS Basic UDI-DI 04050147022959UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04050147022959 UDI-DI Date1 Oct 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
HYBRIDknife® flex T-Type EUDAMED
Erbe GUDID
Generic Name
Endoscopic electrosurgical submucosal lift/resection instrument
Device Name
HYBRIDknife® flex
Model / Reference
20150-111
Primary DI / UDI-DI
04050147022959
Basic UDI-DI
4050147HYBRIDknifeflex-GS
Direct Marketing DI
04050147022959
510(k) Number
FDA Product Code
GEI, FQH
EMDN Code
K0201010301 Open electrosurgery electrodes, single-use
GMDN Term
Endoscopic electrosurgical submucosal lift/resection instrument
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400, 880.5475
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 2.3 Meter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005498

Related devices

Category: Open-surgery electrosurgical electrode, monopolar, single-use

Other devices from Erbe Elektromedizin GmbH

See all devices from Erbe Elektromedizin GmbH →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Endocrine Disruptor
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No