Identity
- Trade Name
- Black Line Lux nach hinten gewinkelt, 4mm EUDAMED
- Device Name
- Black Line Lux nach hinten gewinkelt, 4mm EUDAMED
- Model / Reference
- BLUX4CA2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G375BLUX4CA2 EUDAMED
- Basic UDI-DI
- ++G375BLUX4CA27P EUDAMED
- EMDN Code
- L159009 ODONTOSTOMATOLOGY SCALERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Latvia 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
Black Line Lux nach hinten gewinkelt, 4mm 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 | ++G375BLUX4CA27P | Class I | Active |
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Manufacturer
- Manufacturer
- Immane Corporation
- EUDAMED SRN
- PK-MF-000035233
- Authorised Representative
- CS Active LV-AR-000011602
Sources (1)
- EUDAMED 6cd1dc91-2ac4-4355-908e-291c786f4083 61 fields · synced Jul 25, 2026