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Superfrost™ Microscope Slides

by New Erie Scientific LLC 232 variants

Ref AA00008632E01MNZ50

Superfrost™ Microscope Slides (AA00008632E01MNZ50) is a device classified as Class A in the EU and Class I in the US made by New Erie Scientific LLC, registered in EUDAMED on 18 Aug 2025 (Basic UDI-DI 081004133NES001MN) and listed in FDA GUDID since 5 Mar 2025 (UDI-DI 00810041339348), active as of 24 Oct 2026.

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

CE IVDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081004133NES001MN Basic UDI-DI 00810041339348UDI-DIDate18 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00810041339348 UDI-DI Date5 Mar 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081004133NES001MN registered 18 Aug 2025 Active
  • FDA GUDID UDI-DI 00810041339348 listed 5 Mar 2025 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 00810041339348
  2. Registered EUDAMED 081004133NES001MN

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  • Withdrawn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™ Microscope Slides EUDAMED
Epredia GUDID
Generic name
General specimen microscopy slide IVD, single-use
Device name
Microscope Slides
Model / Ref / Catalog
AA00008632E01MNZ50, Microscope Slide Non Adhesion
Primary DI / UDI-DI
00810041339348
Basic UDI-DI
081004133NES001MN
Unit of use DI
10810041339345
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 registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AA00008632E01MNZ50
GUDID
Microscope Slide Non Adhesion
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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

Similar devices in this category

Other devices filed under MICROSCOPE SLIDES.

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 (20, all answered No)