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Ambu® SureSight™ Stylet ; medium for tracheal tube I.D. 4.5 – 5.5 mm

by VBM Medizintechnik GmbH

Ref 321900020

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
European UnionCE/MDR EUDAMED Number42501056-1.6.11-P7 Basic UDI-DI 04250105630442UDI-DIDate11 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04250105630442 UDI-DI Date2 Jul 2025ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Ambu® SureSight™ Stylet ; medium for tracheal tube I.D. 4.5 – 5.5 mm EUDAMED
Ambu® SureSight TM Stylet; medium GUDID
Generic Name
Artificial airway stylet, single-use
Device Name
Intubation Aids - CS Intubation Aids
Model / Reference
321900020
Primary DI / UDI-DI
04250105630442
Basic UDI-DI
42501056-1.6.11-P7
FDA Product Code
BSR
EMDN Code
R01038099 Endotracheal tubes - accessories not included in other classes
GMDN Term
Artificial airway stylet, single-use
Models / Variants
Device Class
Class I
Regulation Number
868.5790
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Manufacturer details

EUDAMED SRN
DE-MF-000005907

Other devices from VBM Medizintechnik GmbH

See all devices from VBM Medizintechnik GmbH →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No