Identity
- Trade Name
- Service Oil EUDAMEDMK-dent FDA UDI
- Generic Name
- Surgical instrument maintenance lubricant FDA UDI
- Device Name
- Service Oil EUDAMEDLubricant for maintenance FDA UDI
- Model / Reference
- LU1031 EUDAMEDSERVICE OIL FDA UDI
- Description
- Lubricant for maintenance FDA UDI
Identifiers
- Catalog Number
- LU1031 FDA UDI
- Primary DI / UDI-DI
- +E490LU10311$ EUDAMEDE490LU10311 FDA UDI
- Basic UDI-DI
- ++E490SERVICEOIL9T EUDAMED
- Direct Marketing DI
- +E490LU10311$ EUDAMED
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
- GMDN Term
- Surgical instrument maintenance lubricant 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Service Oil by MK-Dent GmbH — 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 | ++E490SERVICEOIL9T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MK-dent GmbH
- EUDAMED SRN
- DE-MF-000010007
Sources (2)
- EUDAMED b2ad1ecc-3a16-4495-a014-b3270274307b 61 fields · synced Jun 19, 2026
- FDA UDI 5afe989c-484b-42d4-a395-4b1291f6bb9d 35 fields · synced May 30, 2026