Identity
- Trade Name
- Diagnostic Speciality Slides EUDAMED
- Device Name
- Microscope Slides EUDAMED
- Model / Reference
- X7X3094HBHTC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850037343713 EUDAMED
- Basic UDI-DI
- 081004133NES001MN EUDAMED
- Unit of Use DI
- 10850037343710 EUDAMED
- EMDN Code
- W0503900201 MICROSCOPE SLIDES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Category: General specimen microscopy slide IVD, single-use
Diagnostic Speciality Slides by New Erie Scientific LLC — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081004133NES001MN | Class A | Active |
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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 (1)
- EUDAMED 10b6a14f-9aa9-4866-a826-bc91c601f60d 61 fields · synced Jun 18, 2026