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FluoreGuard Mounting Medium (Hard Set) 30 mL
EUDAMEDClass A (EU MDR)
Ref FMH030
Identity
- Trade Name
- FluoreGuard Mounting Medium (Hard Set) 30 mL EUDAMED
- Device Name
- Mounting Media EUDAMED
- Model / Reference
- FMH030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108715719 EUDAMED
- Basic UDI-DI
- 081010871W01030706FC EUDAMED
- Direct Marketing DI
- 00810108715719 EUDAMED
- EMDN Code
- W01030706 MOUNTING MEDIA (HISTOLOGY/CYTOLOGY) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
FluoreGuard Mounting Medium (Hard Set) 30 mL by ScyTek Laboratories Inc. — 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 | 081010871W01030706FC | Class A | Active |
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Manufacturer
- Manufacturer
- ScyTek Laboratories Inc.
- EUDAMED SRN
- US-MF-000023816
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c566cafb-b3b3-41e6-8176-10fc597981f2 61 fields · synced Jul 14, 2026