TRAUS ENDO Series
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- TRAUS ENDO Series EUDAMEDTRAUS ENDO FDA UDI
- Generic Name
- Dental power tool system, line-powered FDA UDI
- Device Name
- TRAUS ENDO Series EUDAMED20:1 TRAUS MCE10XX+TRAUS XEW10+ACL(B)-41EP FDA UDI
- Model / Reference
- BAE03 EUDAMEDDia-Gear EUDAMEDTRAUS ENDO EUDAMEDBA182510 EUDAMEDOptima E+BAE370R EUDAMEDTRAUS ENDO #1 FDA UDI
- Description
- 20:1 TRAUS MCE10XX+TRAUS XEW10+ACL(B)-41EP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809260473317 EUDAMED08809260473263 EUDAMED08809260470743 EUDAMEDFDA UDI08809260473270 EUDAMED08809260473331 EUDAMED08809260473348 EUDAMED
- Basic UDI-DI
- B-08809260473317 EUDAMEDB-08809260473263 EUDAMEDB-08809260470743 EUDAMEDB-08809260473270 EUDAMEDB-08809260473331 EUDAMEDB-08809260473348 EUDAMED
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental power tool system, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 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
TRAUS ENDO Series by Saeshin Precision Co., Ltd. — Class IIa — 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-08809260473317 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (7)
- EUDAMED 089e0eea-2840-4d1b-9a5b-c4bbb2396be1 61 fields · synced Jul 30, 2026
- EUDAMED 5f7948b3-e159-4c52-9b2f-a6e64768d8c2 61 fields · synced May 16, 2026
- EUDAMED 1a639d1c-bd7e-483d-8f51-96c081d514ad 61 fields · synced May 17, 2026
- EUDAMED a7dcb543-5327-49e5-98ae-76d78f4b6e8a 61 fields · synced May 18, 2026
- EUDAMED a5ba06d4-e712-4bc6-9b3d-f75baf865306 61 fields · synced May 19, 2026
- EUDAMED 87721065-f194-4366-80a3-36d0cdba10a4 61 fields · synced May 19, 2026
- FDA UDI 21abf037-622d-4a2f-8bcd-5e5c640e9765 33 fields · synced May 30, 2026