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ATMOS HL 21 LED (examination set)

by ATMOS MedizinTechnik GmbH & Co. KG

Ref 507.4505.0Model Headlights

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04250365155488 UDI-DI Date27 Nov 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number42503651ENTVisHL21P9 Basic UDI-DI 04250365155488UDI-DIDate29 Nov 2022RegisteredStatusActive

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.

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  • Withdrawn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
ATMOS HL 21 LED (examination set) EUDAMED
Atmos GUDID
Generic Name
Head-worn lamp
Model / Reference
Headlights EUDAMED
507.4505.0 EUDAMED
HL 21 LED (examination set) GUDID
Primary DI / UDI-DI
04250365155488
Basic UDI-DI
42503651ENTVisHL21P9
FDA Product Code
KZF
EMDN Code
Z12010702 Mobile scialytic lamps
GMDN Term
Head-worn lamp
Device Class
Class I
Regulation Number
880.6320
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Headlights
507.4505.0
GUDID
HL 21 LED (examination set)

Manufacturer details

EUDAMED SRN
DE-MF-000005570

Other devices from ATMOS MedizinTechnik GmbH & Co. KG

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Properties

  • Premarket Exempt
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No