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Cytopro Cytocentrifuge
EUDAMEDFDA UDIClass A (EU MDR)
Ref Model 7622Model Aerospray
Identity
- Trade Name
- Cytopro Cytocentrifuge EUDAMEDCytopro® Cytocentrifuge FDA UDI
- Generic Name
- Centrifugal sample concentrator FDA UDI
- Device Name
- TThe Cytopro Cytocentrifuge is an in vitro diagnostic medical device for fixing biological cell suspensions on glass microscope slides for cytological examination. The Cytopro can be used with the following cell suspensions: Bronchoalveolar liquid (BAL), Cerebrospinal fluid (CSF), Urine, Synovial fluid, And many more. FDA UDI
- Model / Reference
- Aerospray EUDAMEDModel 7622 EUDAMEDFDA UDI
- Description
- TThe Cytopro Cytocentrifuge is an in vitro diagnostic medical device for fixing biological cell suspensions on glass microscope slides for cytological examination. The Cytopro can be used with the following cell suspensions: Bronchoalveolar liquid (BAL), Cerebrospinal fluid (CSF), Urine, Synovial fluid, And many more. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540303975 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661540AerosprayG8 EUDAMED
- Direct Marketing DI
- 03661540303975 EUDAMED
- FDA Product Code
- IFB FDA UDI
- EMDN Code
- W02069004 CYTOCENTRIFUGES EUDAMED
- GMDN Term
- Centrifugal sample concentrator FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3300 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
Cytopro Cytocentrifuge 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 4e9c0491-3373-4363-b382-16c11309a629 61 fields · synced Jun 19, 2026
- FDA UDI 325889b2-70a2-4263-b295-fb2bd0de7718 34 fields · synced May 30, 2026