Identity
- Trade Name
- EA 50 250mL EUDAMED
- Device Name
- EA 50 250mL EUDAMED
- Model / Reference
- BKEA00003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698934340570 EUDAMED
- Basic UDI-DI
- 869893434BKEA00003BJ 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 250mL 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 | 869893434BKEA00003BJ | Class A | Active |
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Manufacturer
- Manufacturer
- Medikal Olusum Sanayi ve Ticaret Limited Sirketi
- EUDAMED SRN
- TR-MF-000026274
Sources (1)
- EUDAMED 27791ebc-75bd-40df-8003-55c56b02a158 61 fields · synced Oct 6, 2026