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Aerospray Cytology 12-Slide Carousel
EUDAMEDFDA UDIClass A (EU MDR)
Ref AC-195Model Aerospray
Identity
- Trade Name
- Aerospray Cytology 12-Slide Carousel EUDAMEDAerospray® Cytology 12-Slide Carousel FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- For use with the Aerospray Cytology Slide Stainer/Cytocentrifuge. FDA UDI
- Model / Reference
- Aerospray EUDAMEDAC-195 EUDAMEDFDA UDI
- Description
- For use with the Aerospray Cytology Slide Stainer/Cytocentrifuge. FDA UDI
Identifiers
- Catalog Number
- AC-195 FDA UDI
- Primary DI / UDI-DI
- 03661540304590 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540AerosprayG8 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059099 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Aerospray Cytology 12-Slide Carousel by Elitechgroup Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 8ff868ca-87a4-4c66-af93-6fa5b49a4a07 61 fields · synced Jul 13, 2026
- FDA UDI c7d75ead-37e9-4b3e-b606-012d5b5e505b 34 fields · synced May 30, 2026