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Implant Surgery Unit 10ft-Extended
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AEU-6000-EXT
Identity
- Trade Name
- Aseptico FDA UDI
- Generic Name
- Dental surgical power tool motor, electric FDA UDI
- Device Name
- IMPLANT SURGERY UNIT 10FT-EXTENDED EUDAMEDImplant/ Endodontic Dental System FDA UDI
- Model / Reference
- AEU-6000-EXT EUDAMEDFDA UDI
- Description
- Implant/ Endodontic Dental System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10817417020982 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10817417020982 EUDAMED
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental surgical power tool motor, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Italy 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
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
Yes
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
Implant Surgery Unit 10ft-Extended by Aseptico, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-10817417020982 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aseptico, Inc.
- EUDAMED SRN
- US-MF-000014012
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 0943865f-1aee-4dcc-a6c2-e5f51624d3d2 61 fields · synced Jun 19, 2026
- FDA UDI c8b72256-5de9-4c2a-bf5c-4323d6c244ad 35 fields · synced May 26, 2026