Identity
- Trade Name
- 37-40% Neutral Buffered Formaldehyde 5L EUDAMED
- Device Name
- 37-40% Neutral Buffered Formaldehyde 5L EUDAMED
- Model / Reference
- BKFO00002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698934340044 EUDAMED
- Basic UDI-DI
- 869893434BKFO00002HP EUDAMED
- EMDN Code
- W01030705 FIXING REAGENTS (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
37-40% Neutral Buffered Formaldehyde 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 | 869893434BKFO00002HP | Class A | Active |
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Manufacturer
- Manufacturer
- Medikal Olusum Sanayi ve Ticaret Limited Sirketi
- EUDAMED SRN
- TR-MF-000026274
Sources (1)
- EUDAMED e43d1839-7b28-4544-83ac-215663ec6fc4 61 fields · synced Oct 7, 2026