Identity
- Trade Name
- Aseptico EUDAMEDFDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Device Name
- GO ULTRA PORTABLE DENTAL SYSTEM EUDAMEDAEU-350 Portable Dentistry System FDA UDI
- Model / Reference
- AEU-350 EUDAMEDFDA UDI
- Description
- AEU-350 Portable Dentistry System FDA UDI
Identifiers
- Catalog Number
- AEU-350 FDA UDI
- Primary DI / UDI-DI
- 10817417022306 EUDAMEDFDA UDI
- Basic UDI-DI
- 081741702dentalunitsX4 EUDAMED
- 510(k) Number
- K130693 FDA UDI
- FDA Product Code
- EIA FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental delivery system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Market of Registration
- Germany 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Aseptico by Aseptico, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081741702dentalunitsX4 | 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 78ceefac-3f2e-4fd6-9b1f-cecc37a2d2fc 61 fields · synced Aug 2, 2026
- FDA UDI 6edf2f4e-1f5b-46fc-b507-2b86ee2cb307 38 fields · synced May 30, 2026