Ultrasonic Surgical Series
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Ultrasonic Surgical Series EUDAMEDTRAUS SUS10 FDA UDI
- Generic Name
- Dental power tool system, line-powered FDA UDI
- Device Name
- Ultrasonic Surgical Series EUDAMED145.3(L) x 23.8(D) FDA UDI
- Model / Reference
- PEZ10XX EUDAMEDPEX10XX EUDAMEDTRAUS PEZ10XX FDA UDI
- Description
- 145.3(L) x 23.8(D) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809260470125 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809260470125 EUDAMED
- FDA Product Code
- EGS FDA UDIEBW FDA UDIDZI 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 I FDA UDI
- Regulation Number
- 872.4200 FDA UDI872.4120 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
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
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809260470125 | 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 28e53b22-9d61-4a1b-85f8-d95da031d5c7 61 fields · synced Jun 19, 2026
- FDA UDI eb98fc73-5da1-4009-9899-a3fb141758f2 33 fields · synced May 30, 2026