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Enbio Data Viewer 17

by Enbio Group AG

Part of a family of 24 devices: see the family page

Ref Software (Enbio Data Viewer) ver. 17Model Enbio S

Enbio Data Viewer 17 is a steam sterilizer (EU MDR Class IIa; FDA Class II; FDA product code FLE, Sterilizer, Steam) made by Enbio Group AG, registered in EUDAMED on 9 Jul 2026 (Basic UDI-DI 7629999sterilizersM2) and listed in FDA GUDID since 1 Mar 2022 (UDI-DI 07629999504721), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7629999sterilizersM2 Basic UDI-DI 07629999504721UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07629999504721 UDI-DI Date1 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7629999sterilizersM2 registered 9 Jul 2026 Active
  • FDA GUDID UDI-DI 07629999504721 listed 1 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07629999504721
  2. Registered EUDAMED 7629999sterilizersM2

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  • Withdrawn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
Enbio Data Viewer
Generic name
Steam sterilizer
Device name
Enbio S
Model / reference
Enbio S EUDAMED
Software (Enbio Data Viewer) ver. 17 EUDAMED
17 GUDID
Primary DI / UDI-DI
07629999504721
Basic UDI-DI
7629999sterilizersM2
Direct marketing DI
07629999504721
FDA product code
FLE
EMDN code
Z12011305 Small load autoclaves with a chamber smaller than 1 standard sterilisation unit
GMDN term
Steam sterilizer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6880
EU registration type
Standard device
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Enbio S
Software (Enbio Data Viewer) ver. 17
GUDID
17
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Steam sterilizer

Similar devices in this category

Other devices filed under SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT.

Other devices from Enbio Group AG

See all devices from Enbio Group AG →

Properties

  • Over-the-counter
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)