Identity
- Trade Name
- Opaster EUDAMED
- Device Name
- OPASTER High Level Disinfectant for Medical Devices and Endoscopes EUDAMED
- Model / Reference
- Opaster EUDAMED89729 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684391100000 EUDAMED
- Basic UDI-DI
- B-08684391100000 EUDAMED
- EMDN Code
- D010103 ORTHOPHTALALDEHYDE FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
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
Opaster by Ecolab Temi̇zleme Si̇stemleri̇ Ltd.şti̇. — Class IIb — 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-08684391100000 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ecolab Temi̇zleme Si̇stemleri̇ Ltd.şti̇.
- EUDAMED SRN
- TR-MF-000021173
Sources (1)
- EUDAMED bd4fb063-33c9-4863-8d81-b32f26eea600 61 fields · synced Jun 19, 2026