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STATIM 5000S Cassette Autoclave

EUDAMED

Class IIa (EU MDR)

Ref 01-222317Ref 01-222318-LRef 01-222313Ref 01-222303

by Dent4You AG

Identity

Trade Name
STATIM 5000S Cassette Autoclave EUDAMED
Device Name
STATIM 5000S Cassette Autoclave EUDAMED
Model / Reference
01-222317 EUDAMED
01-222318-L EUDAMED
01-222313 EUDAMED
01-222303 EUDAMED

Identifiers

Primary DI / UDI-DI
07640397420086 EUDAMED
07640397420758 EUDAMED
07640397422226 EUDAMED
07640397420079 EUDAMED
Basic UDI-DI
764018507STATIM5000S3S EUDAMED
EMDN Code
Z12011305 SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

STATIM 5000S Cassette Autoclave by Dent4You AG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Dent4You AG
EUDAMED SRN
CH-MF-000028926
Authorised Representative
Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Sources (4)

  • EUDAMED 172bf7a2-7fc6-4df7-a778-db83bc105bbc 61 fields · synced Aug 5, 2026
  • EUDAMED a4a87b19-04cb-4fad-97c8-1d20553a19be 61 fields · synced May 16, 2026
  • EUDAMED 33bb76ef-a68d-4c0b-ac14-83a052c31ea7 61 fields · synced May 17, 2026
  • EUDAMED c5009158-6190-4ba3-bc8f-19b1546a89f5 61 fields · synced May 17, 2026