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Disposable laryngoscope blade

by Shenzhen Besdata Technology Co., Ltd 7 variants

Ref Mil1Model Mil0, Mil1, Mac1, Mac2, Mac3, Mac4, D-blade

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, 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
United StatesGUDID listing GUDID Number06971355350529 UDI-DI Date4 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697135535216593 Basic UDI-DI 06971355350529UDI-DIDate13 Aug 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Disposable laryngoscope blade EUDAMED
Besdata GUDID
Generic Name
Video intubation laryngoscope handle/monitor
Model / Reference
Mil0, Mil1, Mac1, Mac2, Mac3, Mac4, D-blade
Primary DI / UDI-DI
06971355350529
Basic UDI-DI
697135535216593
FDA Product Code
CCW
EMDN Code
R9002 Laryngoscope blades, single-use
GMDN Term
Video intubation laryngoscope handle/monitor
Device Class
Class I
Regulation Number
868.5540
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000018921
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Besdata Technology Co., Ltd

See all devices from Shenzhen Besdata Technology Co., Ltd →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing 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
  • 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