Ermis ER100.050E
Ref ER100.050E
Ermis ER100.050E 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 04049224250088), active as of 24 Oct 2026.
Active
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number4049224ContainerDQ 04049224250088 | Date13 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04049224250088 | Date14 Apr 2017 | StatusListed |
Official records
- EUDAMED public site 4049224ContainerDQ
- AccessGUDID record 04049224250088
Across registries
- EUDAMED Basic UDI-DI 4049224ContainerDQ registered 13 Oct 2026 Active
- FDA GUDID UDI-DI 04049224250088 listed 14 Apr 2017 Listed
Timeline
- Listed FDA GUDID 04049224250088
- Registered EUDAMED 4049224ContainerDQ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Ermis
- Generic name
- Device sterilization/disinfection container, reusable
- Device name
- Sterilisationscontainer
- Model / Ref / Catalog
- ER100.050E
- Primary DI / UDI-DI
- 04049224250088
- Basic UDI-DI
- 4049224ContainerDQ
- 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 EUDAMEDClass 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
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
| Sterilise before use | No | Yes |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 04049224250088: EUDAMED states No, FDA GUDID states Yes.
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.
Similar devices in this category
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