Identity
- Trade Name
- Alsil Gum 20 Shore -5Kg Silicone Rubber EUDAMEDProsthetic Silicone Materials FDA UDI
- Generic Name
- External limb prosthesis finishing component, custom-made FDA UDI
- Device Name
- Prosthetic Silicone Materials EUDAMEDSilicone materials for manufacture of adhesive or implant retained external maxillofacial materials FDA UDI
- Model / Reference
- AL20B EUDAMEDAlSil Gum 20 Shore – 5kg FDA UDI
- Description
- Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials FDA UDI
Identifiers
- Catalog Number
- AL20B FDA UDI
- Primary DI / UDI-DI
- 05060483016207 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048301TF3D9 EUDAMED
- Direct Marketing DI
- 05060483016207 EUDAMED
- FDA Product Code
- GBI FDA UDI
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
- GMDN Term
- External limb prosthesis finishing component, custom-made FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.3800 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: External limb prosthesis finishing component, custom-made
Prosthetic Silicone Materials by Technovent Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as External limb prosthesis finishing component, custom-made.
- Prosthetic Silicone Materials — TECHNOVENT LIMITED · Class I
- Prosthetic Silicone Materials — TECHNOVENT LIMITED · Class I
- Prosthetic Silicone Materials — TECHNOVENT LIMITED · Class I
- Prosthetic Silicone Materials — TECHNOVENT LIMITED · Class I
- Prosthetic Silicone Materials — TECHNOVENT LIMITED · Class I
- Prosthetic Silicone Materials — TECHNOVENT LIMITED · Class I
- Prosthetic Silicone Materials — TECHNOVENT LIMITED · Class I
- Prosthetic Silicone Materials — TECHNOVENT LIMITED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Technovent Limited
Sources (2)
- FDA UDI fa69a01d-bb38-41aa-a8ba-ae24b0432c63 35 fields · synced Jul 27, 2026
- EUDAMED 46e2458d-7787-43df-8ca6-bcd0ab6ce619 61 fields · synced Jul 27, 2026