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Mouth Opener
EUDAMEDClass I (EU MDR)
Ref MouthopenerModel 3001.01, 3001.02, 3001.03, 3002.01, 3002.02, 3002.03, 3003.01, 3003.02, 3003.03, 3004.01, 3007.01, 3007.02
Identity
- Device Name
- Mouth Opener EUDAMED
- Model / Reference
- 3001.01, 3001.02, 3001.03, 3002.01, 3002.02, 3002.03, 3003.01, 3003.02, 3003.03, 3004.01, 3007.01, 3007.02 EUDAMEDMouthopener EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978315815203 EUDAMED
- Basic UDI-DI
- 697831581MouthopenerVU EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
The Mouth Opener is a medical device designed for the initial opening of the mouth, allowing for easier access to various medical procedures. By providing a safe and effective way to manage obstructive conditions, this device has been carefully engineered to meet the specific needs of healthcare professionals.
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 | 697831581MouthopenerVU | Class I | Active |
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Manufacturer
- Manufacturer
- Wuxi Weller Technology Co., LTD
- EUDAMED SRN
- CN-MF-000046706
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2181f023-89b5-4504-acbd-ef0ce36468f3 61 fields · synced Aug 1, 2026