Identity
- Trade Name
- EA 50 500mL EUDAMED
- Device Name
- EA 50 500mL EUDAMED
- Model / Reference
- BKEA00002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698934340563 EUDAMED
- Basic UDI-DI
- 869893434BKEA00002BG EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
EA 50 500mL by Medikal Olusum Sanayi ve Ticaret Limited Sirketi — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 869893434BKEA00002BG | Class A | Active |
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Manufacturer
- Manufacturer
- Medikal Olusum Sanayi ve Ticaret Limited Sirketi
- EUDAMED SRN
- TR-MF-000026274
Sources (1)
- EUDAMED 6d566925-08ba-49b2-81c2-7004ce38a9d5 61 fields · synced Jun 18, 2026