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100x10 8mm allergEAZE clear Patch Test Chambers

by SmartPractice United States EUDAMED510(k)GUDID

Ref AL67730GENModel allergEAZE clear Patch Test Chambers Product code KXFEMDN A99

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0854498007AL71300ZE Basic UDI-DIDate29 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00854498007115 UDI-DIDate2 Dec 2020ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK103409 Date15 Mar 2011IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Trade Name
100x10 8mm allergEAZE clear Patch Test Chambers EUDAMED
SmartPractice GUDID
Generic Name
Allergy testing adhesive strip, epicutaneous
Model / Ref / Catalog
allergEAZE clear Patch Test Chambers EUDAMED
AL67730GEN EUDAMED
AL71300 GUDID
Primary DI / UDI-DI
00854498007115
Basic UDI-DI
0854498007AL71300ZE
Unit of Use DI
10854498007112
510(k) Number
FDA Product Code
KXF
EMDN Code
A99 Devices for administration, withdrawal and collection - other
GMDN Term
Allergy testing adhesive strip, epicutaneous
Device Class
Class I
Regulation Number
880.6025
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
allergEAZE clear Patch Test Chambers
AL67730GEN
GUDID
AL71300

Manufacturer details

EUDAMED SRN
US-MF-000005657
Authorised representative
Dr. Ebeling & Assoc. GmbH DE-AR-000000003

Other devices from SmartPractice

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Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Administering Medicine
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 4dfb6661-3f5b-4988-8776-30e6ad807b43 61 fields · synced 24 Oct 2026
  • FDA UDI b95dd1f0-d27c-4dfa-a838-7530668ab654 36 fields · synced 30 May 2026
  • FDA 510(k) K103409 1 fields · synced 18 May 2026