Identity
- Trade Name
- Delta.36 EUDAMEDDelta. 36 FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- Slide Stainer EUDAMEDThe Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in histology laboratories. FDA UDI
- Model / Reference
- PC900 EUDAMEDSS1-DCS EUDAMEDFDA UDI
- Description
- The Slide Stainer is a fully automated slide processing system for staining paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. This universal system is designed to automate the manual staining methods routinely used in histology laboratories. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G225SS1DCS0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++G225instrumentTR EUDAMED
- Direct Marketing DI
- G225SS1DCS0 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059001 IMMUNOHISTOCHEMISTRY PROCESSORS 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
Delta.36 by Pathcom Systems Corporation — 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 | ++G225instrumentTR | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Pathcom Systems Corporation
- EUDAMED SRN
- US-MF-000023790
- Authorised Representative
- Hab Gov Strategics Applied Technologies Limited MT-AR-000020568
Sources (2)
- EUDAMED 96418752-8d60-413c-9177-f54e87a59b03 61 fields · synced Jul 29, 2026
- FDA UDI 68dde75e-c86a-418c-9193-22d2e1a90c28 33 fields · synced May 30, 2026