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DFK air

by Zumax Medical CO., LTD. 15 variants

Ref 50PL3000

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69450955binocularloupesYV Basic UDI-DI Date16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945095541059 UDI-DI Date29 May 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.

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  • Withdrawn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
DFK air EUDAMED
zumax GUDID
Generic Name
Surgical binoculars, reusable
Device Name
Binocular Loupes
Model / Ref / Catalog
50PL3000, DFK air
Primary DI / UDI-DI
06945095541059, 06945095541073, 06945095541066
Basic UDI-DI
69450955binocularloupesYV
FDA Product Code
HJH
EMDN Code
Q0299 Ophthalmic devices - other
GMDN Term
Surgical binoculars, reusable
Device Class
Class I
Regulation Number
886.5120
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
50PL3000
GUDID
DFK air

Manufacturer details

EUDAMED SRN
CN-MF-000011126
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Zumax Medical Co., LTD

See all devices from Zumax Medical Co., LTD →

Properties

  • Premarket Exempt
  • Lot / Batch 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
  • Serial Number: No
  • Expiration Date: No