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Lumatas Titan Autostainer
EUDAMEDFDA UDIClass A (EU MDR)
Ref Lumatas Titan AutostainerModel Titan
Identity
- Trade Name
- Lumatas Titan Autostainer EUDAMEDLumatas Automated Slide Stainer FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- Lumatas Automated Slide Stainer EUDAMEDThis Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemistry such as the application of immuno-reagents (antibodies) to tissue sections. FDA UDI
- Model / Reference
- Titan EUDAMEDFDA UDILumatas Titan Autostainer EUDAMED
- Description
- This Automated Slide Stainer is to automate tissue staining procedures used in immunohistochemistry such as the application of immuno-reagents (antibodies) to tissue sections. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850042030004 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850042030Titan83 EUDAMED
- Direct Marketing DI
- 00850042030004 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
Yes
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
Lumatas Titan Autostainer by Lumatas Biosystems, 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 | 0850042030Titan83 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Lumatas BioSystems Inc
- EUDAMED SRN
- US-MF-000017316
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6b0240ee-4084-436f-9f99-5257d26a5b62 61 fields · synced Jul 16, 2026
- FDA UDI bd15ae0c-b633-43db-86e0-fd626e72b9af 34 fields · synced May 29, 2026