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STATIM 2000S Cassette Autoclave
EUDAMEDClass IIa (EU MDR)
Ref 01-152302-LRef 01-152314Ref 01-152304Ref 01-152302-R
by Dent4You AG
Identity
- Trade Name
- STATIM 2000S Cassette Autoclave EUDAMED
- Device Name
- STATIM 2000S Cassette Autoclave EUDAMED
- Model / Reference
- 01-152302-L EUDAMED01-152314 EUDAMED01-152304 EUDAMED01-152302-R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640397420048 EUDAMED07640397422219 EUDAMED07640397420062 EUDAMED07640397420055 EUDAMED
- Basic UDI-DI
- 764018507STATIM2000S2R 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 2000S 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764018507STATIM2000S2R | Class IIa | Active |
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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 330bab52-d3db-451b-af77-39399d5a3e6f 61 fields · synced Jul 12, 2026
- EUDAMED 48566ff5-0987-4ca9-b784-44285aaec357 61 fields · synced May 17, 2026
- EUDAMED 7f8a26fd-e6c6-4a8b-9895-9b2efec8d83f 61 fields · synced May 18, 2026
- EUDAMED fce62629-09b8-4d50-bc31-d2c8a4b2100a 61 fields · synced May 19, 2026