Laserguard Silicone Bite Guard
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Medasil teeth protector FDA UDI
- Generic Name
- Mouthguard, single-use FDA UDI
- Device Name
- Laserguard Silicone Bite Guard EUDAMEDsilicone, laser resistant sterile, 20 pieces/box FDA UDI
- Model / Reference
- 520-1120-0002 EUDAMED50-250-00 FDA UDI
- Description
- silicone, laser resistant sterile, 20 pieces/box FDA UDI
Identifiers
- Catalog Number
- 50-250-00 FDA UDI
- Primary DI / UDI-DI
- 05060465562654 EUDAMEDFDA UDI
- Basic UDI-DI
- 506046556520-11C9 EUDAMED
- Unit of Use DI
- 05060465562647 EUDAMED
- FDA Product Code
- BRW FDA UDI
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
- GMDN Term
- Mouthguard, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5820 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
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
No
Manufacturing Date
Yes
Category: Radiation/mechanical corneal shield, reusable
Laserguard Silicone Bite Guard by Medasil Surgical Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 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 (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506046556520-11C9 | Class I | Active |
| 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
- Medasil Surgical Limited
- EUDAMED SRN
- GB-MF-000009549
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (2)
- EUDAMED 63027d98-eacc-4135-8665-7b529788a77c 61 fields · synced Jun 18, 2026
- FDA UDI 0825abbe-b7ad-4a5c-91d3-577d705fc9ae 35 fields · synced May 30, 2026