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STATIM 6000B G4+ Vacuum Autoclave
EUDAMEDClass IIa (EU MDR)
Ref G4-700013Ref G4-700013-RRef G4-700001-RRef G4-700005-RRef G4-700001Ref G4-700005
by Dent4You AG
Identity
- Trade Name
- STATIM 6000B G4+ Vacuum Autoclave EUDAMED
- Device Name
- STATIM 6000B G4+ Vacuum Autoclave EUDAMED
- Model / Reference
- G4-700013 EUDAMEDG4-700013-R EUDAMEDG4-700001-R EUDAMEDG4-700005-R EUDAMEDG4-700001 EUDAMEDG4-700005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640397420024 EUDAMED07640397422127 EUDAMED07640397422103 EUDAMED07640397422110 EUDAMED07640397420000 EUDAMED07640397420017 EUDAMED
- Basic UDI-DI
- 764018507STATIMBVQ 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 6000B G4+ Vacuum 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 | 764018507STATIMBVQ | 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 (6)
- EUDAMED 1cf73815-4b06-4ea7-b1d3-d2f1bca5c8f0 61 fields · synced Sep 18, 2026
- EUDAMED 1b7d5fcc-bb74-47cc-97cc-99af97514be6 61 fields · synced May 17, 2026
- EUDAMED 1b274b64-4af0-42b4-a6e4-4d9dab3dc199 61 fields · synced May 17, 2026
- EUDAMED 475e3ad4-7616-4532-87ce-2fe4a37da8c0 61 fields · synced May 18, 2026
- EUDAMED 0ed254ec-52ea-4aba-b7e6-ad00facbcee5 61 fields · synced May 18, 2026
- EUDAMED b2398edb-0154-49d8-93dc-0dae964c8578 61 fields · synced May 18, 2026