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Aerospray Hematology Stat Reagent D, Aerofix Fixative
EUDAMEDClass A (EU MDR)
Ref SS-048Model Aerospray Stains Ref SS-148-EU
Identity
- Trade Name
- Aerospray Hematology Stat Reagent D, Aerofix Fixative EUDAMEDAerospray Hematology Stat Reagent D Aerofix Fixative Concentrate EUDAMED
- Model / Reference
- Aerospray Stains EUDAMEDSS-048 EUDAMEDSS-148-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661540302350 EUDAMED03661540303845 EUDAMED
- Basic UDI-DI
- 3661540Aerospray-StainXL EUDAMED
- Direct Marketing DI
- 03661540302350 EUDAMED03661540303845 EUDAMED
- EMDN Code
- W0103010302 ROMANOWSKY STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Aerospray Hematology Stat Reagent D, Aerofix Fixative by Elitechgroup 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 | 3661540Aerospray-StainXL | Class A | Active |
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Manufacturer
- Manufacturer
- ELITechGroup Inc.
- EUDAMED SRN
- US-MF-000006942
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 5550a009-43e9-4378-9c10-fe924f7def27 61 fields · synced Jul 25, 2026
- EUDAMED 10380b85-aba5-494d-981c-2551895d5945 61 fields · synced May 17, 2026