Skip to content

ScalpelCric

by VBM Medizintechnik GmbH Germany EUDAMED510(k)GUDID

Ref 30-08-447-1 Product code BWCEMDN R010699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number42501056-1.3.7-VP Basic UDI-DIDate17 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250105630770 UDI-DIDate21 Dec 2022ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK200190 Date30 Oct 2020IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Generic Name
Cricothyrotomy kit, single-use
Device Name
Cricothyrotomy - ScalpelCric
Model / Reference
30-08-447-1
Primary DI / UDI-DI
04250105630770, 04250105629736
Basic UDI-DI
42501056-1.3.7-VP
510(k) Number
FDA Product Code
BWC, JOH
EMDN Code
R010699 Percutaneous tracheostomy kits - other
GMDN Term
Cricothyrotomy kit, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5090, 868.5800
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005907

Other devices from VBM Medizintechnik GmbH

See all devices from VBM Medizintechnik GmbH →

Properties & raw data

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

Sources (5)

  • EUDAMED cbb605d6-e4a0-4d82-a9b8-bfafa4c7dfe3 61 fields · synced 24 Oct 2026
  • EUDAMED 04250105629736|42501056-1.3.7-VP 61 fields · synced 17 May 2026
  • FDA UDI 82d8d297-76ba-492d-baf2-c3a868e539cb 35 fields · synced 29 May 2026
  • FDA UDI 476ff1a3-b968-4b8f-a3e7-7426442e7020 36 fields · synced 23 Oct 2026
  • FDA 510(k) K200190 1 fields · synced 18 May 2026