Identity
- Trade Name
- Microtome Knife EUDAMEDEpredia FDA UDI
- Generic Name
- Microtome blade IVD, reusable FDA UDI
- Device Name
- Blades and Knives EUDAMEDThe blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use. FDA UDI
- Model / Reference
- 152020 EUDAMEDMicrotome Knife, 16 CM, C FDA UDI
- Description
- The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use. FDA UDI
Identifiers
- Catalog Number
- 152020 FDA UDI
- Primary DI / UDI-DI
- 00673693063500 EUDAMEDFDA UDI
- Basic UDI-DI
- 0673693RAS017RN EUDAMED
- Direct Marketing DI
- 00673693063500 EUDAMED
- FDA Product Code
- IDL FDA UDI
- EMDN Code
- W0202059085 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES EUDAMED
- GMDN Term
- Microtome blade IVD, reusable FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microtome blade IVD, reusable
Epredia by Richard-Allan Scientific LLC — 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
- Richard-Allan Scientific LLC
Sources (2)
- FDA UDI 3bb21370-99b7-4dd9-9f8e-06e4fb4f56a1 34 fields · synced Jul 17, 2026
- EUDAMED 264ca850-1867-4a53-992b-ba1e635ce278 61 fields · synced Jul 17, 2026