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Sterile Silicone Surgical Sheet
EUDAMEDClass IIb (EU MDR)
Ref 640-1101-1000Ref 640-1101-0000
Identity
- Device Name
- Sterile Silicone Surgical Sheet EUDAMED
- Model / Reference
- 640-1101-1000 EUDAMED640-1101-0000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060465562579 EUDAMED05060465562555 EUDAMED
- Basic UDI-DI
- 506046556640-11DC EUDAMED
- EMDN Code
- M04040701 SILICONE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Silicone Surgical Sheet by Medasil Surgical Limited — Class IIb — 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 | 506046556640-11DC | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medasil Surgical Limited
- EUDAMED SRN
- GB-MF-000009549
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (2)
- EUDAMED 06d4d20e-eed7-4acb-ba9f-f1808e3f4840 61 fields · synced Oct 6, 2026
- EUDAMED fdcf86c7-1d6a-416f-84c0-96d1af3e8e88 61 fields · synced May 17, 2026