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AlphaSMART

by Gimmi GmbH 4 variants

Ref CAM.1113.00

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4049047ZAE23ASA27DREZ7 Basic UDI-DI 04049047788553UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049047788553 UDI-DI Date4 Mar 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
AlphaSMART EUDAMED
Gimmi GUDID
Generic Name
Endoscope video camera
Device Name
AlphaSMART Camera & Accessories
Model / Reference
CAM.1113.00
Description
AlphaSMART Camera Head Full HD Zoom
Primary DI / UDI-DI
04049047788553
Basic UDI-DI
4049047ZAE23ASA27DREZ7
Direct Marketing DI
04049047788553
510(k) Number
FDA Product Code
FET
EMDN Code
Z12020405 Surgical cameras
GMDN Term
Endoscope video camera
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Hydrogen Peroxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005445

Other devices from Gimmi GmbH

See all devices from Gimmi GmbH →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No