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Diagnostic Speciality Slides

by New Erie Scientific LLC 17 variants

Ref X1XER314W, X1XER315L, X1XCM324O, X1XER302W, X1XER304B, X1XER312B, X1XER314B, X1XER309B, X1XER313B, X1XER305B, X1XER307W, X1XER306W, X1XCM321L

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081004133NES001MN Basic UDI-DI Date18 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00850037343218 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  • Withdrawn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
Diagnostic Speciality Slides EUDAMED
Epredia GUDID
Generic Name
General specimen microscopy slide IVD, single-use
Device Name
Microscope Slides
Model / Ref / Catalog
X1XER314W, X1XER315L, X1XCM324O, X1XER302W, X1XER304B, X1XER312B, X1XER314B, X1XER309B, X1XER313B, X1XER305B, X1XER307W, X1XER306W, X1XCM321L, Microscope Slide Non Adhesion, 30-3834H-BL-CC-CE, X2XER208B, X7X30256HBHTC, X8X307AWCE, X1XES3105L, X8X308HRHTC, X8X301179ARCE, X1XER332L, X7X30141HBHTC, X1XES306W, X8X30819HRHTC, X7X30370HBHTC, X8X307HRHTC, X2XCM210R, 30-3456A-BK-CE24, X2XCM221R, X8X30503ABCE, X2XCM204R, X2XER201B, X7X3031HBHTC, X2XER207W, X7X30563HBHTC, X8X3086ABCE, 30-3699SBN-LM100CE, X7X3021HRHTC, X2XCM201R, X1XER368B
Primary DI / UDI-DI
00850037343218, 00850037343232, 00850037343058, 00850037343089, 00850037343102, 00850037343188, 00850037343201, 00850037343164, 00850037343195, 00850037343119, 00850037343140, 00850037343133, 00850037343041, 00850037343898, 00850037343430, 00850037343652, 00850037343805, 00850037343294, 00850037343867, 00850037343720, 00850037343256, 00850037343614, 00850037343287, 00850037343836, 00850037343676, 00850037343812, 00850037343355, 00850037343935, 00850037343362, 00850037343782, 00850037343348, 00850037343379, 00850037343669, 00850037343423, 00850037343683, 00850037343843, 00850037343928, 00850037343621, 00850037343324, 00850037343263
Basic UDI-DI
081004133NES001MN
Unit of Use DI
10850037343215, 10850037343239, 10850037343055, 10850037343086, 10850037343109, 10850037343185, 10850037343208, 10850037343161, 10850037343192, 10850037343116, 10850037343147, 10850037343130, 10850037343048
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
X1XER314W
X1XER315L
X1XCM324O
X1XER302W
X1XER304B
X1XER312B
X1XER314B
X1XER309B
X1XER313B
X1XER305B
X1XER307W
X1XER306W
X1XCM321L
GUDID
Microscope Slide Non Adhesion
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