Identity
- Trade Name
- Sil-Fixx EUDAMEDSil-Fixx 1.9cm x 5M EUDAMED
- Device Name
- Sil-Fixx 1.9cm x 1.5M EUDAMEDSil-Fixx EUDAMED
- Model / Reference
- SF1915 EUDAMEDSil-Fixx EUDAMEDSF 1950 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973596010217 EUDAMED06973596010712 EUDAMED
- Basic UDI-DI
- 697359601Sil-FixxGE EUDAMED697359601SilFixx6T EUDAMED
- Direct Marketing DI
- 06973596010217 EUDAMED06973596010712 EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMEDM0303010201 ELASTIC FIXING BANDAGES, SELF-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDBelgium 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
Sil-Fixx by Conlett Technology Inc — 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 | 697359601Sil-FixxGE | Class I | Active |
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Manufacturer
- Manufacturer
- Conlett Technology Inc
- EUDAMED SRN
- CN-MF-000002101
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 0d90d032-dad7-4dcd-8282-f210ceddd6e8 61 fields · synced Jul 10, 2026
- EUDAMED ed104d41-f9a8-4796-ae15-24aa0d80da51 61 fields · synced May 19, 2026