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Ermis ER100.030E

by Ermis MedTech GmbH

Ref ER100.030E

Ermis ER100.030E is a device classified as Class I in the EU and Class II in the US made by Ermis MedTech GmbH, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 4049224ContainerDQ) and listed in FDA GUDID since 14 Apr 2017 (UDI-DI 04049224249990), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4049224ContainerDQ Basic UDI-DI 04049224249990UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049224249990 UDI-DI Date14 Apr 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4049224ContainerDQ registered 13 Oct 2026 Active
  • FDA GUDID UDI-DI 04049224249990 listed 14 Apr 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049224249990
  2. Registered EUDAMED 4049224ContainerDQ

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  • Withdrawn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
Sterilisationscontainer EUDAMED
Ermis GUDID
Generic name
Device sterilization/disinfection container, reusable
Model / Ref / Catalog
ER100.030E
Primary DI / UDI-DI
04049224249990
Basic UDI-DI
4049224ContainerDQ
Direct marketing DI
04049224249990
FDA product code
KCT
EMDN code
S010401 Trays, baskets, tubs for sterilisation and their components
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6850
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Device sterilization/disinfection container, reusable

Similar devices in this category

Other devices filed under DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z).

Other devices from Ermis MedTech GmbH

See all devices from Ermis MedTech GmbH →

Properties

  • Sterilise before use
  • Over-the-counter
  • Lot / batch number
Other properties (22, all answered No)