Identity
- Trade Name
- iMED Tooth Protector EUDAMED
- Device Name
- iMED Tooth Protector EUDAMED
- Model / Reference
- 19-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05745000816019 EUDAMED
- Basic UDI-DI
- 5745000816TPTPE7N EUDAMED
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
iMED Tooth Protector by iMED ApS — 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 | 5745000816TPTPE7N | Class I | Active |
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Manufacturer
- Manufacturer
- iMED ApS
- EUDAMED SRN
- DK-MF-000032070
Sources (1)
- EUDAMED 066ebb89-6719-4594-9e41-772a395a7680 61 fields · synced Jul 10, 2026