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Aerospray® Cytology Stain F Empty Bottle w/Level Detect
EUDAMEDFDA UDIClass A (EU MDR)
Ref AC-197Model Aerospray Stains
Identity
- Trade Name
- Aerospray® Cytology Stain F Empty Bottle w/Level Detect EUDAMEDStain F Empty Bottle with Level Detect, Cytology Stainer FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- Stain F Empty Bottle with Level Detect, Cytology Stainer FDA UDI
- Model / Reference
- Aerospray Stains EUDAMEDAC-197 EUDAMEDFDA UDI
- Description
- Stain F Empty Bottle with Level Detect, Cytology Stainer FDA UDI
Identifiers
- Catalog Number
- AC-197 FDA UDI
- Primary DI / UDI-DI
- 03661540304613 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540Aerospray-StainXL EUDAMED
- Direct Marketing DI
- 03661540304613 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
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Aerospray® Cytology Stain F Empty Bottle w/Level Detect by Elitechgroup Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 3661540Aerospray-StainXL | 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 014a3435-f299-4f2b-a06c-01aa353a9326 61 fields · synced Jun 18, 2026
- FDA UDI dd0af57e-8d89-4fae-9301-a34bb37de44e 35 fields · synced May 30, 2026