Identity
- Trade Name
- Insil EUDAMED
- Device Name
- Insil EUDAMED
- Model / Reference
- CR3941 EUDAMEDCR3942 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031484878 EUDAMED05060031484847 EUDAMED
- Basic UDI-DI
- 506003148InsilGM EUDAMED
- EMDN Code
- M050101 PLASTERS ON SPOOLS (ROLLS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDIreland 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
Insil by Brightwake 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 | 506003148InsilGM | Class I | Active |
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Manufacturer
- Manufacturer
- Brightwake Limited
- EUDAMED SRN
- GB-MF-000012039
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (2)
- EUDAMED 31cd7a8d-5627-4dcb-ac1c-8ae6a68434a6 61 fields · synced Sep 18, 2026
- EUDAMED b283438b-0d49-42a7-8f29-188677c5b2d9 61 fields · synced May 17, 2026