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Enbio PRO (ver. USA/CAN)

by Enbio Group AG

Ref ENBIO PROModel Enbio S

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7629999sterilizersM2 Basic UDI-DI 07629999900769UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07629999900769 UDI-DI Date2 Mar 2026ListedStatusListed 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.

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  • Withdrawn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

Generic Name
Steam sterilizer
Device Name
Enbio S
Model / Reference
Enbio S EUDAMED
ENBIO PRO EUDAMED
Enbio PRO (ver. USA/CAN) GUDID
Primary DI / UDI-DI
07629999900769
Basic UDI-DI
7629999sterilizersM2
Direct Marketing DI
07629999900769
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 market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Enbio S
ENBIO PRO
GUDID
Enbio PRO (ver. USA/CAN)
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Enbio Group AG

See all devices from Enbio Group AG →

Properties

  • Over-the-Counter
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No