Identity
- Trade Name
- Xylene Histological Grade 5L EUDAMED
- Device Name
- Xylene Histological Grade 5L EUDAMED
- Model / Reference
- BKKS00002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681349080513 EUDAMED
- Basic UDI-DI
- 86813490805BKKS00002JA EUDAMED
- EMDN Code
- W01030708,W01030799 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
Xylene Histological Grade 5L 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 | 86813490805BKKS00002JA | Class A | Active |
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Manufacturer
- Manufacturer
- Medikal Olusum Sanayi ve Ticaret Limited Sirketi
- EUDAMED SRN
- TR-MF-000026274
Sources (1)
- EUDAMED c821cc34-b11d-4b64-8f3d-9fac8a9691ed 61 fields · synced Oct 6, 2026