Identity
- Trade Name
- 1:1 Dispensing Gun round end EUDAMED
- Device Name
- Prosthetic Silicone Materials EUDAMED
- Model / Reference
- G802b EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060483016139 EUDAMED
- Basic UDI-DI
- 506048301TF3D9 EUDAMED
- Direct Marketing DI
- 05060483016139 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
1:1 Dispensing Gun round end by Technovent Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506048301TF3D9 | Class I | Active |
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Manufacturer
- Manufacturer
- Technovent Limited
- EUDAMED SRN
- GB-MF-000006738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 4926ad44-2358-49b6-bca5-5212adb70c43 61 fields · synced Jul 15, 2026