Identity
- Device Name
- Sterile Silicone Bite Guards EUDAMED
- Model / Reference
- 05060465560087 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060465560087 EUDAMED
- Basic UDI-DI
- 506046556101-11A6 EUDAMED
- Unit of Use DI
- 05060465560070 EUDAMED
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Category: Radiation/mechanical corneal shield, reusable
Sterile Silicone Bite Guards by Medasil Surgical Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiation/mechanical corneal shield, reusable.
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- SOFT CARE — BOURNAS MEDICALS · Class I
- STOCKINETTE ROULEE 1/1 COTON ECRU 15x150 M6 — MAILL'TUB · Class I
- CONCHIGLIA OCULARE — Surgika srl · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Sani-Tab Chain-Free Econoback Towels — CROSSTEX INTERNATIONAL, INC. · Class I
- Champ Fenêtré Adhésif — JiangSu MedPlus Non-Woven Manufacturer Co., Ltd · Class I
- Simplex-Plus Maxi kék nyálkendő — Dentalia Dentálgyártmány Kft. · Class I
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 | 506046556101-11A6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medasil Surgical Limited
- EUDAMED SRN
- GB-MF-000009549
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED 81353f68-287c-4456-900e-9a56e2e5c71a 61 fields · synced Jul 20, 2026