Identity
- Trade Name
- GUM Ortho Wax EUDAMED
- Device Name
- GUM ORTHO WAX EUDAMED
- Model / Reference
- 723BX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 17630019900017 EUDAMED
- Basic UDI-DI
- 76300199GUMORTHOWAXLV EUDAMED
- EMDN Code
- Q01020203 OCCLUSAL WAXES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
GUM Ortho Wax by Sunstar Europe SA — 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 | 76300199GUMORTHOWAXLV | Class I | Active |
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Manufacturer
- Manufacturer
- Sunstar Europe SA
- EUDAMED SRN
- CH-MF-000023162
- Authorised Representative
- Sunstar France FR-AR-000018318
Sources (1)
- EUDAMED 652701a5-a1e0-4d0e-8eb0-77c1b9ab4de4 61 fields · synced Jun 19, 2026