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Aerospray Hematology Stat Slide Stainer/Cytocentrifuge
EUDAMEDFDA UDIClass A (EU MDR)
Ref Model 7122Model Aerospray
Identity
- Trade Name
- Aerospray Hematology Stat Slide Stainer/Cytocentrifuge EUDAMEDFDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- The Aerospray Hematology Stat Slide Stainer/Cytocentrifuge (Model 7122) is intended for use by medical professionals to stain specimens that may include blood and other body fluids, as a step of standard laboratory practice in diagnosing disease in humans. Addition of the Cytopro rotor allows preparation of slides by cytocentrifugation before staining. FDA UDI
- Model / Reference
- Aerospray EUDAMEDModel 7122 EUDAMEDFDA UDI
- Description
- The Aerospray Hematology Stat Slide Stainer/Cytocentrifuge (Model 7122) is intended for use by medical professionals to stain specimens that may include blood and other body fluids, as a step of standard laboratory practice in diagnosing disease in humans. Addition of the Cytopro rotor allows preparation of slides by cytocentrifugation before staining. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540303937 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540AerosprayG8 EUDAMED
- Direct Marketing DI
- 03661540303937 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Microscope slide stainer IVD
Aerospray Hematology Stat Slide Stainer/Cytocentrifuge by Elitechgroup Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 3661540AerosprayG8 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 ef015f11-f1a2-47eb-a84d-d087edfbe926 61 fields · synced Jul 20, 2026
- FDA UDI 611cc175-fa5a-42c8-9e75-baef6fa9ccae 34 fields · synced May 30, 2026