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Silicone Bite Guard Blue- Non-Sterile.
EUDAMEDClass I (EU MDR)
Ref 101-1020-1200
Identity
- Device Name
- Silicone Bite Guard Blue- Non-Sterile. EUDAMED
- Model / Reference
- 101-1020-1200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060465560063 EUDAMED
- Basic UDI-DI
- 506046556101-10A4 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
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
Yes
EUDAMED
Silicone Bite Guard Blue- Non-Sterile. by Medasil Surgical 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 | 506046556101-10A4 | Class I | 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 (1)
- EUDAMED 798775ca-bfd0-4992-86a1-a9232706d8b9 61 fields · synced Jun 19, 2026