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VALO™ Barrier Sleeves VALO Corded 600 Barrier Sleeves Refill

by Minitube AB EUDAMEDGUDID

Active European Union

Ref 5897

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07350069421838 UDI-DIDate1 May 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++B9764000006K Basic UDI-DIDate15 Dec 2021RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
VALO™ Barrier Sleeves
Generic Name
Medical equipment/instrument drape, single-use
Device Name
Disposable infection control barrier
Model / Ref / Catalog
5897, VALO Corded 600 Barrier Sleeves Refill
Primary DI / UDI-DI
07350069421838
Basic UDI-DI
++B9764000006K
Unit of Use DI
07350069420831
510(k) Number
FDA Product Code
PEM
EMDN Code
T030102 Cover sheaths, instruments and equipments
GMDN Term
Medical equipment/instrument drape, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4370
Market of Registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5897
GUDID
VALO Corded 600 Barrier Sleeves Refill
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Medical equipment/instrument drape, single-use

Cleared under the same submission (K211026)

Show all (10)

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Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No