Identity
- Trade Name
- Ultrasonic Surgical Series EUDAMEDTRAUS SUS20 FDA UDI
- Generic Name
- Dental power tool system, line-powered FDA UDI
- Device Name
- Ultrasonic Surgical Series EUDAMEDoptic / BUS20+FUS10+PEZ10LN FDA UDI
- Model / Reference
- SUS20 EUDAMEDTRAUS SUS20#1 FDA UDI
- Description
- optic / BUS20+FUS10+PEZ10LN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809260472143 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809260472143 EUDAMED
- 510(k) Number
- K192561 FDA UDI
- FDA Product Code
- DZI FDA UDI
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental power tool system, line-powered FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4120 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electrical-only medical device connection cable, reusable
Ultrasonic Surgical Series by Saeshin Precision Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809260472143 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Saeshin Precision Co., Ltd.
- EUDAMED SRN
- KR-MF-000016345
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (2)
- EUDAMED 8e04e00a-45db-4ddb-9a69-0f7244662883 61 fields · synced Jul 12, 2026
- FDA UDI a58be202-613f-42cb-a8b7-377cc6392e88 34 fields · synced May 30, 2026