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Actodent Spray
EUDAMEDClass I (EU MDR)
Ref 03.7403.500Model Medical Device Lubricating Spray
by ACTO GmbH
Identity
- Trade Name
- Actodent Spray EUDAMED
- Device Name
- Spray Oil EUDAMED
- Model / Reference
- Medical Device Lubricating Spray EUDAMED03.7403.500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250108374046 EUDAMED
- Basic UDI-DI
- 4250108324.IMLS.01TH EUDAMED
- Direct Marketing DI
- 04250108374046 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Actodent Spray by ACTO GmbH — 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 | 4250108324.IMLS.01TH | Class I | Active |
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Manufacturer
- Manufacturer
- ACTO GmbH
- EUDAMED SRN
- DE-MF-000019128
Sources (1)
- EUDAMED 41af51ed-5370-43c0-88bb-417c570db4a6 61 fields · synced Oct 7, 2026