Identity
- Trade Name
- Tissue Freezing Medium EUDAMEDLeica Biosystems FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Frozen Section Compound EUDAMEDTissue freezing medium, 125 ml FDA UDI
- Model / Reference
- 14020108926 EUDAMEDFDA UDI
- Description
- Tissue freezing medium, 125 ml FDA UDI
Identifiers
- Catalog Number
- 14020108926 FDA UDI
- Primary DI / UDI-DI
- 00849832012214 EUDAMED10849832012211 FDA UDI
- Basic UDI-DI
- 849832005UP EUDAMED
- Direct Marketing DI
- 00849832012214 EUDAMED
- FDA Product Code
- KEQ FDA UDI
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Biological stain IVD
Leica Biosystems by Leica Biosystems Richmond, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Richmond, Inc.
Sources (2)
- FDA UDI b848bf43-9939-4736-a78f-49ba71f1e775 37 fields · synced Jun 19, 2026
- EUDAMED df04e00d-34a7-456a-9f95-1404ca7c4d49 61 fields · synced Jun 19, 2026