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STATIM 5000 G4 Cassette Autoclave
EUDAMEDClass IIa (EU MDR)
Ref G4-222315-LRef G4-232314-LRef G4-232306Ref G4-222315Ref G4-232313Ref G4-232317Ref G4-222317-RRef G4-222303Ref G4-232314Ref G4-222314-LRef G4-222303-RRef G4-222313Ref G4-232314-R
by Dent4You AG
Identity
- Trade Name
- STATIM 5000 G4 Cassette Autoclave EUDAMED
- Device Name
- STATIM 5000 G4 Cassette Autoclave EUDAMED
- Model / Reference
- G4-222315-L EUDAMEDG4-232314-L EUDAMEDG4-232306 EUDAMEDG4-222315 EUDAMEDG4-232313 EUDAMEDG4-232317 EUDAMEDG4-222317-R EUDAMEDG4-222303 EUDAMEDG4-232314 EUDAMEDG4-222314-L EUDAMEDG4-222303-R EUDAMEDG4-222313 EUDAMEDG4-232314-R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640397420260 EUDAMED07640397421007 EUDAMED07640397420321 EUDAMED07640397420246 EUDAMED07640397422264 EUDAMED07640397420284 EUDAMED07640397420215 EUDAMED07640397420222 EUDAMED07640397420987 EUDAMED07640397420970 EUDAMED07640397420239 EUDAMED07640397422257 EUDAMED07640397420994 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
- 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 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 (13)
- EUDAMED 6e160a5f-3ac6-46d6-9967-1b5588ab4133 61 fields · synced Aug 2, 2026
- EUDAMED c32bcf2c-7b5d-4d8c-9606-5f88a19dc544 61 fields · synced May 11, 2026
- EUDAMED ee6cfb0e-7f88-4bf4-804b-3f4acf114fdf 61 fields · synced May 11, 2026
- EUDAMED eb6d9308-24c9-416e-ad4f-e4550ac31f53 61 fields · synced May 17, 2026
- EUDAMED 4adb8dd6-4415-40e7-a3aa-615c2f2bacc2 61 fields · synced May 17, 2026
- EUDAMED b1da81c8-354f-4e4d-9c7a-a59394ef0817 61 fields · synced May 18, 2026
- EUDAMED 5fc3a8d8-3dde-41af-bf6f-8ba31573abb8 61 fields · synced May 18, 2026
- EUDAMED f42ac391-2edd-4e4d-9c9e-6c8aa76c9261 61 fields · synced May 18, 2026
- EUDAMED c3af249e-336b-4f60-81c6-1fd29475f4fa 61 fields · synced May 18, 2026
- EUDAMED 9c44112a-1f99-4953-8edc-becf4dc9d1b3 61 fields · synced May 18, 2026
- EUDAMED 86851c70-ebf4-4313-b33d-0cb953a387f0 61 fields · synced May 18, 2026
- EUDAMED f3b9bee6-9e34-4404-b878-a3f117dfeb18 61 fields · synced May 18, 2026
- EUDAMED 18aca33f-6817-4660-8269-3d578d09d1b1 61 fields · synced May 18, 2026