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Sterilized Disposable Blade/Model:Mac-3M

by Hebei Vimed Medical Device Company, LTD

Ref 3102306

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971834830597 UDI-DI Date30 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number6971834830001AV Basic UDI-DI 06971834830597UDI-DIDate15 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Sterilized Disposable Blade/Model:Mac-3M EUDAMED
Sterilized Disposable Blade GUDID
Generic Name
Video intubation laryngoscope blade
Device Name
Mac-3M sterilized single-use blade (disposable blade)
Model / Reference
3102306 EUDAMED
Mac-3M GUDID
Primary DI / UDI-DI
06971834830597
Basic UDI-DI
6971834830001AV
Direct Marketing DI
06971834830597
FDA Product Code
CCW
EMDN Code
R9002 Laryngoscope blades, single-use
GMDN Term
Video intubation laryngoscope blade
Device Class
Class I
Regulation Number
868.5540
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
3102306
GUDID
Mac-3M

Manufacturer details

EUDAMED SRN
CN-MF-000002086
Authorised representative
Supporting Health Care N.V. NL-AR-000001835

Other devices from Hebei Vimed Medical Device Company, Ltd.

See all devices from Hebei Vimed Medical Device Company, Ltd. →

Properties

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

Other properties (19)

  • 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
  • Manufacturing Date: No