Identity
- Trade Name
- Peloris Parablocks EUDAMEDLeica Biosystems FDA UDI
- Generic Name
- Paraffin-based embedding medium IVD FDA UDI
- Device Name
- Wax EUDAMEDPeloris Parablocks X-tra FDA UDI
- Model / Reference
- 39V3001 EUDAMEDFDA UDI
- Description
- Peloris Parablocks X-tra FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10849832021664 EUDAMEDFDA UDI
- Basic UDI-DI
- 849832001UF EUDAMED
- Unit of Use DI
- 00849832021667 EUDAMED
- FDA Product Code
- KEO FDA UDI
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
- GMDN Term
- Paraffin-based embedding medium 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
No
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: Paraffin-based embedding medium 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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- Leica Biosystems — Leica Biosystems Richmond, Inc. · Class I
- Leica Biosystems — Leica Biosystems Richmond, Inc. · Class I
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 e3368014-229d-4806-bffd-42cb923e4e98 36 fields · synced Jul 17, 2026
- EUDAMED 1c501485-da7c-4d1e-89ba-639198f100d9 61 fields · synced Jul 17, 2026