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Root elevators
EUDAMEDClass I (EU MDR)
Ref IMC-53-003-00Model IMC5300300Ref IMC-53-302-00Model IMC5330200
Identity
- Trade Name
- Root elevators EUDAMED
- Device Name
- Root elevator EUDAMED
- Model / Reference
- IMC5300300 EUDAMEDIMC-53-003-00 EUDAMEDIMC5330200 EUDAMEDIMC-53-302-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G375IMC53003000 EUDAMEDG375IMC53302000 EUDAMED
- Basic UDI-DI
- ++G375IMC5300300M4 EUDAMED++G375IMC5330200MY EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Root elevators by Immane Corporation — Class I — 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 | ++G375IMC5300300M4 | Class I | Active |
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Manufacturer
- Manufacturer
- Immane Corporation
- EUDAMED SRN
- PK-MF-000035233
- Authorised Representative
- CS Active LV-AR-000011602
Sources (2)
- EUDAMED 4947ecc5-9786-4b6c-94ea-ac562eb9516a 61 fields · synced Jul 15, 2026
- EUDAMED 85ba8d3d-2515-4a2b-afb4-ee7d355d22d4 61 fields · synced May 18, 2026