Identity
- Trade Name
- Leica Autostainer XL (ST5010) EUDAMEDAXL 230-240V/50-60 Hz FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- Leica Autostainer XL (ST5010) EUDAMEDThe Leica Autostainer XL (ST5010) is an IVD (in-vitro diagnostics) instrument. The Leica Autostainer XL (ST5010) is a stainer for la boratory applications and intended for the preparation of histological and cytological tissue samples. FDA UDI
- Model / Reference
- 14045635136 EUDAMED000000014045635136 FDA UDI
- Description
- The Leica Autostainer XL (ST5010) is an IVD (in-vitro diagnostics) instrument. The Leica Autostainer XL (ST5010) is a stainer for la boratory applications and intended for the preparation of histological and cytological tissue samples. FDA UDI
Identifiers
- Catalog Number
- 14045635136 FDA UDI
- Primary DI / UDI-DI
- 04049188073174 EUDAMEDFDA UDI
- Basic UDI-DI
- 010404918804569X 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
Yes
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
Yes
FDA UDI
Leica Autostainer XL (ST5010) by Leica Biosystems Nussloch Gmbh — 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 | 010404918804569X | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Nussloch GmbH
- EUDAMED SRN
- DE-MF-000021943
Sources (2)
- EUDAMED 33718e50-9860-4968-a4f5-a77bf68197db 61 fields · synced Aug 2, 2026
- FDA UDI 21940069-fed4-4990-ad3f-c0c9c7764fd9 37 fields · synced May 29, 2026