← Back to catalogue
Aerospray Hematology Pro Reagent A, Buffer (pH 6.8)
EUDAMEDClass A (EU MDR)
Ref SS-071AModel Aerospray Stains
Identity
- Trade Name
- Aerospray Hematology Pro Reagent A, Buffer (pH 6.8) EUDAMED
- Model / Reference
- Aerospray Stains EUDAMEDSS-071A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03661540302558 EUDAMED
- Basic UDI-DI
- 3661540Aerospray-StainXL EUDAMED
- Direct Marketing DI
- 03661540302558 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 6.8) 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ELITechGroup Inc.
- EUDAMED SRN
- US-MF-000006942
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 2b804031-c9f1-4ee8-b698-e1935f3daf41 61 fields · synced Jun 19, 2026