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Aerospray Hematology Pro Reagent A, Buffer (pH 7.2) Concentrate
EUDAMEDClass A (EU MDR)
Ref SS-172A-EUModel Aerospray Stains
Identity
- Trade Name
- Aerospray Hematology Pro Reagent A, Buffer (pH 7.2) Concentrate EUDAMED
- Model / Reference
- Aerospray Stains EUDAMEDSS-172A-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661540303821 EUDAMED
- Basic UDI-DI
- 3661540Aerospray-StainXL EUDAMED
- Direct Marketing DI
- 03661540303821 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 Pro Reagent A, Buffer (pH 7.2) Concentrate 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 (1)
- EUDAMED 7b552d39-33bf-4f90-b825-fd8d972f81e3 61 fields · synced Jul 10, 2026