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STATIM 5000 G4 Cassette Autoclave
EUDAMEDClass IIa (EU MDR)
Ref G4-222314
by Dent4You AG
Identity
- Trade Name
- STATIM 5000 G4 Cassette Autoclave EUDAMED
- Device Name
- STATIM 5000 G4 Cassette Autoclave EUDAMED
- Model / Reference
- G4-222314 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640397420956 EUDAMED
- Basic UDI-DI
- 764018507STATIM5000G4U4 EUDAMED
- EMDN Code
- Z12011305 SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT EUDAMED
Classification
- Device Class
- Class IIa 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 5000 G4 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 | 764018507STATIM5000G4U4 | 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 (1)
- EUDAMED 7d7c1ab4-5408-4ff0-b769-b0ff349562cc 61 fields · synced May 29, 2026