Identity
- Trade Name
- Servo 8E, grey EUDAMEDLMDental FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Cassette and tray system for dental instruments EUDAMEDServo 8E, grey, Servo Tray FDA UDI
- Model / Reference
- 6581 EUDAMEDFDA UDI
- Description
- Servo 8E, grey, Servo Tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311218274 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311CASSETTES10KT EUDAMED
- Direct Marketing DI
- 06438311218274 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Finland 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Servo 8E, grey by LM-Instruments Oy — 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 | 6438311CASSETTES10KT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (2)
- EUDAMED 9881ef24-c5c7-466b-85cc-055aa436e1cb 61 fields · synced Jun 19, 2026
- FDA UDI 21d6b54b-9732-40a4-8ce2-2b2e90c3a064 33 fields · synced May 30, 2026