Identity
- Trade Name
- A.Titan Instruments EUDAMEDA. Titan Instruments FDA UDISeptodont FDA UDI
- Generic Name
- Dental anaesthesia syringe, reusable FDA UDI
- Device Name
- Aspirating/Self Aspirating Dental Injection syringe EUDAMEDAspirating Syringe, Metric, Medium, Blue FDA UDISelf-Aspirating Syringe, Standard Thread, Medium, Stainless FDA UDI
- Model / Reference
- SE-8200 EUDAMEDFDA UDIAMMC-5 FDA UDI
- Description
- Aspirating Syringe, Metric, Medium, Blue FDA UDISelf-Aspirating Syringe, Standard Thread, Medium, Stainless FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841685103804 EUDAMEDFDA UDI00841685105327 FDA UDI
- Basic UDI-DI
- 08416851K092943VC EUDAMED
- Direct Marketing DI
- 00841685103804 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
Category: Dental anaesthesia syringe, reusable
A. Titan Instruments by A.Titan Instruments — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- A.Titan Instruments
Sources (3)
- FDA UDI 07dcfdaf-e42a-4c72-a8a7-38e550a6c1f1 33 fields · synced Sep 30, 2026
- FDA UDI 334c60c7-6ea8-4cf1-8f11-56d241383829 33 fields · synced May 29, 2026
- EUDAMED 101d579f-499c-480f-8142-652aec66e1dd 61 fields · synced Jul 8, 2026