Air Motor & Air Handpiece
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- AIR MOTOR & AIR HANDPIECE EUDAMEDAIR MOTOR & AIR HANDPIECE & COUPLING EUDAMEDTRAUS Air Dental Handpiece FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Device Name
- AIR MOTOR & AIR HANDPIECE EUDAMEDAIR MOTOR & AIR HANDPIECE & COUPLING EUDAMEDTRAUS ATN400 FDA UDI
- Model / Reference
- MRD22NN/ACL(B)-01C/AT-II/CAB20NDM4 EUDAMEDCP10NQ EUDAMEDCP10LK EUDAMEDATN400 EUDAMEDTRAUS ATN400 #1 FDA UDI
- Description
- TRAUS ATN400 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809260471849 EUDAMED08809260473409 EUDAMED08809260473416 EUDAMED08809260473003 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809260471849 EUDAMEDB-08809260473409 EUDAMEDB-08809260473416 EUDAMEDB-08809260473003 EUDAMED
- 510(k) Number
- K221741 FDA UDI
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental surgical power tool motorized handpiece/set, pneumatic 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
Yes
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
Air Motor & Air Handpiece 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-08809260471849 | 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 (5)
- EUDAMED 8738cff8-9c83-403f-bcc0-da598b9dace8 61 fields · synced Jul 23, 2026
- EUDAMED e2c203c2-dbc5-4511-b575-027bea9632a1 61 fields · synced May 17, 2026
- EUDAMED 56a2ab69-4f19-48a1-8435-7aea8fc83c1c 61 fields · synced May 18, 2026
- EUDAMED fc094ff0-bb37-465e-bdc8-7cf66d6c7be2 61 fields · synced May 19, 2026
- FDA UDI 4f755dd4-ff64-419a-b547-7958a73c2210 34 fields · synced May 30, 2026