Identity
- Trade Name
- Soan EUDAMEDFDA UDI
- Generic Name
- Dental computer assisted anaesthesia injection unit FDA UDI
- Device Name
- Soan EUDAMED1 Soan handpiece 1 wireless pedal 1 battery charger 1 power supply, 5 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521) FDA UDI
- Model / Reference
- Soan1 EUDAMEDFDA UDI
- Description
- 1 Soan handpiece 1 wireless pedal 1 battery charger 1 power supply, 5 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521) FDA UDI
Identifiers
- Catalog Number
- SOAN1 FDA UDI
- Primary DI / UDI-DI
- 03760349809951 EUDAMED03760349805335 FDA UDI
- Basic UDI-DI
- 376034980SOANGU EUDAMED
- Direct Marketing DI
- 03760349809951 EUDAMED
- FDA Product Code
- DZM FDA UDIEJI FDA UDI
- EMDN Code
- A020203 CARTRIDGE SYRINGES EUDAMED
- GMDN Term
- Dental computer assisted anaesthesia injection unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4730 FDA UDI872.6770 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Soan by Dentalhitec — 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 | 376034980SOANGU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Dentalhitec
- EUDAMED SRN
- FR-MF-000003716
Sources (2)
- EUDAMED d7fc6b1c-d7a3-4cdf-86e8-2b105bcd612f 61 fields · synced Jul 12, 2026
- FDA UDI a7501893-5779-49ce-8a3d-447f0525ee4d 35 fields · synced May 29, 2026