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Formal Saline 10%
EUDAMEDClass A (EU MDR)
Ref RRFF4001-I-BBModel Cytology Fixative Solution
Identity
- Trade Name
- Formal Saline 10% EUDAMED
- Model / Reference
- Cytology Fixative Solution EUDAMEDRRFF4001-I-BB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055914765007 EUDAMED
- Basic UDI-DI
- 505591470RRFFEK EUDAMED
- EMDN Code
- W01030705 FIXING REAGENTS (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland 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
Formal Saline 10% by Atom Scientific Ltd — 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 | 505591470RRFFEK | Class A | Active |
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Manufacturer
- Manufacturer
- Atom Scientific Ltd
- EUDAMED SRN
- UK-MF-000046578
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 4610ee89-1641-4c98-9857-532e06f8b531 61 fields · synced Jun 18, 2026