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Sirio
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref V1612EORef V1615EO
by Tecnofar Spa
Identity
- Trade Name
- SIRIO EUDAMEDFDA UDI
- Generic Name
- Dental syringe needle, single-use FDA UDI
- Device Name
- SIRIO DENTAL NEEDLE EUDAMEDDisposable Dental Needle 27Gx35 FDA UDI
- Model / Reference
- V1612EO EUDAMEDV1615EO EUDAMEDSIRIO 27Gx35 FA11 FDA UDI
- Description
- Disposable Dental Needle 27Gx35 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08053610770018 EUDAMED08053610770001 EUDAMED08053610772777 FDA UDI
- Basic UDI-DI
- 805361077AGOGR EUDAMED
- FDA Product Code
- DZM FDA UDI
- EMDN Code
- A010601 CARPULE NEEDLES EUDAMED
- GMDN Term
- Dental syringe needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4730 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental syringe needle, single-use
Sirio by Tecnofar Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental syringe needle, single-use.
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- V-Ject — VERICOM CO., LTD. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- V-Ject — VERICOM CO., LTD. · Class I
- SEPTOJECT 30G SHORT — SEPTODONT SAS SPECIALITES SEPTODONT · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tecnofar Spa
Sources (3)
- FDA UDI 83ddc0a1-b03e-44e6-925c-01c712e5acef 34 fields · synced Jul 21, 2026
- EUDAMED 39605f6e-62ed-4b84-bb4f-acef1398077b 61 fields · synced Jul 11, 2026
- EUDAMED e13ef1b7-7dc2-4202-8154-c85347cc232b 61 fields · synced Jul 21, 2026