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50x10 8mm Finn Chamber on Scanpor OPEN

by SmartPractice

Ref AL16121GENModel Finn Chamber on Scanpor OPEN

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0854498007AL7005WW Basic UDI-DI 00854498007146UDI-DIDate28 Apr 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00854498007146 UDI-DI Date2 Dec 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
50x10 8mm Finn Chamber on Scanpor OPEN EUDAMED
SmartPractice GUDID
Generic Name
Allergy testing adhesive strip, epicutaneous
Device Name
Finn Chamber on Scanpor OPEN
Model / Ref / Catalog
Finn Chamber on Scanpor OPEN EUDAMED
AL16121GEN EUDAMED
AL7005 GUDID
Primary DI / UDI-DI
00854498007146
Basic UDI-DI
0854498007AL7005WW
Unit of Use DI
10854498007143
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Finn Chamber on Scanpor OPEN
AL16121GEN
GUDID
AL7005

Manufacturer details

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

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Properties

  • 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