Identity
- Trade Name
- A.Titan Instruments EUDAMEDSeptodont FDA UDI
- Generic Name
- Dental anaesthesia syringe, reusable FDA UDI
- Device Name
- Aspirating/Self Aspirating Dental Injection syringe EUDAMEDSelf-Aspirating Syringe, Standard Thread, Standard, Stainless, 2.2ml FDA UDI
- Model / Reference
- SE-4210-2 EUDAMEDFDA UDI
- Description
- Self-Aspirating Syringe, Standard Thread, Standard, Stainless, 2.2ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841685105495 EUDAMEDFDA UDI
- Basic UDI-DI
- 08416851K092943VC EUDAMED
- Direct Marketing DI
- 00841685105495 EUDAMED
- FDA Product Code
- EJI FDA UDI
- EMDN Code
- A020203 CARTRIDGE SYRINGES EUDAMED
- GMDN Term
- Dental anaesthesia syringe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6770 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
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
A.Titan Instruments by A.Titan Instruments — Class I — 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 | 08416851K092943VC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- A.Titan Instruments
- EUDAMED SRN
- US-MF-000023452
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED fc8bd173-5793-4067-8d21-16e1ede43591 61 fields · synced Jul 21, 2026
- FDA UDI 681c2e43-9d98-4c36-8316-3788f22e4fe8 33 fields · synced May 30, 2026