Identity
- Trade Name
- Colormark™ Slides EUDAMEDEpredia FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Device Name
- Microscope Slides EUDAMED
- Model / Reference
- B9992000TN EUDAMEDMicroscope Slide Non Adhesion FDA UDI
Identifiers
- Catalog Number
- B9992000TN FDA UDI
- Primary DI / UDI-DI
- 00810041331564 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004133NES001MN EUDAMED
- Unit of Use DI
- 20810041331568 EUDAMED
- FDA Product Code
- KEW FDA UDI
- EMDN Code
- W0503900201 MICROSCOPE SLIDES EUDAMED
- GMDN Term
- General specimen microscopy slide IVD, single-use 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General specimen microscopy slide IVD, single-use
Epredia by New Erie 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
- New Erie Scientific LLC
Sources (2)
- FDA UDI 3f4aa609-3d05-494c-b596-c689c2d48235 33 fields · synced Jul 18, 2026
- EUDAMED 6413a6de-12f1-4b53-b066-aff5e6387566 61 fields · synced Jul 18, 2026