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Rapid Inoculation Fluid 2ml Pk/20
EUDAMEDClass A (EU MDR)
Ref R8325106
by Remel, Inc.
Identity
- Trade Name
- RAPID INOCULATION FLUID 2ML PK/20 EUDAMED
- Device Name
- RAPID INOCULATION FLUID EUDAMED
- Model / Reference
- R8325106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00848838058554 EUDAMED
- Basic UDI-DI
- 8488380RapIDInoculFLLC EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES 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
Rapid Inoculation Fluid 2ml Pk/20 by Remel, 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 | 8488380RapIDInoculFLLC | Class A | Active |
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Manufacturer
- Manufacturer
- Remel, Inc.
- EUDAMED SRN
- US-MF-000044686
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (1)
- EUDAMED ccc1c30d-f2b9-4662-b228-b9fbc8ccf9eb 61 fields · synced Jul 26, 2026