Identity
- Trade Name
- Lubrina 2 EUDAMED
- Device Name
- Lublina 2 EUDAMED
- Model / Reference
- HIM-2 EUDAMEDHIM-2 Type EX2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04548213042616 EUDAMED
- Basic UDI-DI
- 4548213000B0004DT EUDAMED
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Lubrina 2 by J.morita Mfg.corp. — 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 | 4548213000B0004DT | Class I | Active |
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Manufacturer
- Manufacturer
- J. Morita Mfg. Corp.
- EUDAMED SRN
- JP-MF-000023000
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 22191203-9ec8-48cc-9005-42a5a11256ce 61 fields · synced Jul 11, 2026