Identity
- Trade Name
- SOFT CARE EUDAMED
- Model / Reference
- LABORATORY SERIES EUDAMED111.012.IS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05208107003145 EUDAMED
- Basic UDI-DI
- 5208107125000RL EUDAMED
- EMDN Code
- W0503900201 MICROSCOPE SLIDES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: General specimen microscopy slide IVD, single-use
Soft Care by Bournas Medicals — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5208107125000RL | Class A | Active |
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Manufacturer
- Manufacturer
- Bournas Medicals
- EUDAMED SRN
- GR-MF-000023099
Sources (1)
- EUDAMED 18c2bd00-d7ca-4d95-a443-d237a7caa6a8 61 fields · synced Jun 18, 2026