Identity
- Trade Name
- Disposable Mouth guard EUDAMED
- Device Name
- Mouth Guards for Single Use EUDAMED
- Model / Reference
- many EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-MG83 EUDAMED
- Basic UDI-DI
- B-MG83 EUDAMED
- EMDN Code
- Q030399 INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Mouth guard by Jiangsu Kangjin Medical Instrument Co., Ltd — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-MG83 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Kangjin Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000011142
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 5e80ee31-33ba-4c74-b355-7123aae112ad 61 fields · synced Jun 19, 2026