Identity
- Trade Name
- Lubricare 2 EUDAMEDFDA UDI
- Generic Name
- Dental handpiece maintenance unit FDA UDI
- Device Name
- Lublicare2 EUDAMEDHandpiece Maintenance Unit FDA UDI
- Model / Reference
- HIM-2 EUDAMEDHIM-2 Type BA EUDAMEDHIM-2-BA FDA UDI
- Description
- Handpiece Maintenance Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04548213049899 EUDAMEDFDA UDI
- Basic UDI-DI
- 4548213000B0005DV EUDAMED
- 510(k) Number
- K190509 FDA UDI
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Dental handpiece maintenance unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Lubricare 2 by J.morita Mfg.corp. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4548213000B0005DV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED fbbc93da-410d-4b41-b724-0b9f03cfbd57 61 fields · synced Jul 28, 2026
- FDA UDI 6b083559-4911-4a17-a3f8-cf581aaee69c 35 fields · synced May 29, 2026