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Disposable Blade

by Henan Tuoren Kingtaek Medical Device Co., Ltd. China EUDAMEDGUDID

Ref BNVL01Model MD11, MD12, MD21, MD22, MD11-A, MD12-A, MD21-A,MD22-A

Product code CCWEMDN R9002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69705240302TK-DBXY Basic UDI-DIDate7 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06970524032808 UDI-DIDate8 Dec 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Laryngoscope blade, single-use
Model / Reference
MD11 EUDAMED
MD12 EUDAMED
MD21 EUDAMED
MD22 EUDAMED
MD11-A EUDAMED
MD12-A EUDAMED
MD21-A EUDAMED
MD22-A EUDAMED
BNVL01 EUDAMED
I GUDID
Primary DI / UDI-DI
06970524032808, 06970524030811, 06970524031016
Basic UDI-DI
69705240302TK-DBXY
FDA Product Code
CCW
EMDN Code
R9002 Laryngoscope blades, single-use
GMDN Term
Laryngoscope blade, single-use
Device Class
Class I
Regulation Number
868.5540
Market of Registration
Türkiye
Italy
Spain
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MD11, MD12, MD21, MD22, MD11-A, MD12-A, MD21-A,MD22-A
BNVL01
GUDID
I

Manufacturer details

EUDAMED SRN
CN-MF-000015021
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • 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
  • Serial Number: No
  • Manufacturing Date: No

Sources (4)

  • EUDAMED c4a025fa-16ab-4473-b1f5-580b2f8dada2 61 fields · synced 22 Oct 2026
  • EUDAMED 06970524030811|69705240302TK-DBXY 61 fields · synced 17 May 2026
  • FDA UDI 7991b749-2a76-4fe0-8f0c-c75926945f56 32 fields · synced 30 May 2026
  • EUDAMED 06970524031016|69705240302TK-DBXY 61 fields · synced 20 Oct 2026