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Superfrost Plus™ Adhesion Microscope Slides

by New Erie Scientific LLC 15 variants

Ref J1840AMNZ

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Overview

The Adhesion Microscope Slides device is a highly advanced, standardized medical device that facilitates accurate and reliable tissue analysis. Developed by New Erie Scientific LLC, this instrument is designed to provide precise results for various applications in human medicine.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081004133NES001MN Basic UDI-DI 00810041339867UDI-DIDate18 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810041339867 UDI-DI Date11 Mar 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Superfrost Plus™ Adhesion Microscope Slides EUDAMED
Epredia GUDID
Generic Name
General specimen microscopy slide IVD, single-use
Model / Ref / Catalog
J1840AMNZ, Adhesion Microscope Slides
Primary DI / UDI-DI
00810041339867
Basic UDI-DI
081004133NES001MN
Unit of Use DI
10810041339864
FDA Product Code
KEW
EMDN Code
W0503900201 Microscope slides
GMDN Term
General specimen microscopy slide IVD, single-use
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.3010
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
J1840AMNZ
GUDID
Adhesion Microscope Slides
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000008165
Authorised representative
Epredia Netherlands B.V. NL-AR-000001488

Related devices

Category: General specimen microscopy slide IVD, single-use

Other devices from New Erie Scientific LLC

See all devices from New Erie Scientific LLC →

Properties

  • Single Use
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • 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
  • Serial Number: No