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Davis Boyle Mouth Gag - Child
EUDAMEDClass I (EU MDR)
Ref E15-141Model Retractors - Reusable
Identity
- Trade Name
- Davis Boyle Mouth Gag - Child EUDAMED
- Model / Reference
- Retractors - Reusable EUDAMEDE15-141 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060417203086 EUDAMED
- Basic UDI-DI
- 506041720RETRACTOR-RUTB EUDAMED
- EMDN Code
- L14010299 OROPHARYNGAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Mouth gag, adjustable, reusable
Davis Boyle Mouth Gag - Child by Sheffmed Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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- Ambler Surgical — Ambler Surgical, LLC · 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 | 506041720RETRACTOR-RUTB | Class I | Active |
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Manufacturer
- Manufacturer
- Sheffmed Limited
- EUDAMED SRN
- GB-MF-000004158
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED bc4f45cb-157c-4d1f-bf72-dc3d7ec3f639 61 fields · synced Jun 19, 2026