Identity
- Trade Name
- Diagnostic Speciality Slides EUDAMEDEpredia FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Device Name
- Microscope Slides EUDAMED
- Model / Reference
- X1XER301B EUDAMEDMicroscope Slide Non Adhesion FDA UDI
Identifiers
- Catalog Number
- X1XER301B FDA UDI
- Primary DI / UDI-DI
- 00850037343065 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004133NES001MN EUDAMED
- Unit of Use DI
- 10850037343062 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: General specimen microscopy slide IVD, single-use
Diagnostic Speciality Slides by New Erie Scientific LLC — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081004133NES001MN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- New Erie Scientific LLC
- EUDAMED SRN
- US-MF-000008165
- Authorised Representative
- Epredia Netherlands B.V. NL-AR-000001488
Sources (2)
- EUDAMED e208f1c8-6f7f-4a77-9460-626caef91285 61 fields · synced Jun 18, 2026
- FDA UDI 6f78559e-0ed5-4cdf-b14c-69e38c4001ae 33 fields · synced May 30, 2026