Identity
- Trade Name
- Giemsa Solution 250mL EUDAMED
- Device Name
- Giemsa Solution 250mL EUDAMED
- Model / Reference
- BKGS00003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698934340648 EUDAMED
- Basic UDI-DI
- 869893434BKGS00003KW EUDAMED
- EMDN Code
- W0103010302 ROMANOWSKY STAINS 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
Giemsa Solution 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 | 869893434BKGS00003KW | Class A | Active |
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Manufacturer
- Manufacturer
- Medikal Olusum Sanayi ve Ticaret Limited Sirketi
- EUDAMED SRN
- TR-MF-000026274
Sources (1)
- EUDAMED 33846d9a-94b4-4aa7-9a34-8a2a9a406984 61 fields · synced Oct 6, 2026