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Aerospray Gram Slide Stainer/Cytocentrifuge
EUDAMEDFDA UDIClass A (EU MDR)
Ref Model 7322Model Aerospray
Identity
- Trade Name
- Aerospray Gram Slide Stainer/Cytocentrifuge EUDAMEDAerospray® Gram Slide Stainer/Cytocentrifuge FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- The Aerospray Gram stainer is an in vitro diagnostic medical device for professional use only. The Gram stainer has been designed to perform automated Gram staining of pure strain isolate smears and human specimens with microorganisms for in vitro diagnostics with Elitech Group Gram reagents only. FDA UDI
- Model / Reference
- Aerospray EUDAMEDModel 7322 EUDAMEDFDA UDI
- Description
- The Aerospray Gram stainer is an in vitro diagnostic medical device for professional use only. The Gram stainer has been designed to perform automated Gram staining of pure strain isolate smears and human specimens with microorganisms for in vitro diagnostics with Elitech Group Gram reagents only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540303951 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540AerosprayG8 EUDAMED
- Direct Marketing DI
- 03661540303951 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 Gram Slide Stainer/Cytocentrifuge by Elitechgroup Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 541fae27-355b-4761-9ab4-c7cf434e81ad 61 fields · synced Jul 21, 2026
- FDA UDI dbd53c6f-59fc-41a0-8450-2f995c84dd98 34 fields · synced May 30, 2026