Identity
- Trade Name
- Epredia FDA UDI
- Generic Name
- Microscope slide coverslipper IVD FDA UDI
- Device Name
- ClearVue coverslipper- Accessory FDA UDI
- Model / Reference
- Barcode Reader Conversion FDA UDI
- Description
- ClearVue coverslipper- Accessory FDA UDI
Identifiers
- Catalog Number
- A79210200 FDA UDI
- Primary DI / UDI-DI
- 05051663517522 FDA UDI
- FDA Product Code
- KIM FDA UDI
- GMDN Term
- Microscope slide coverslipper IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Microscope slide coverslipper IVD
Epredia by Shandon Diagnostics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Epredia — SHANDON DIAGNOSTICS LIMITED · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shandon Diagnostics Limited
Sources (1)
- FDA UDI 4394f32c-17d8-42bf-b612-ac8fbbfc1818 34 fields · synced May 31, 2026