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VALO™ Barrier Sleeves VALO X 600 Barrier Sleeves Refill

by Minitube AB EUDAMEDGUDID

Active European Union

Ref 5898

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07350069421845 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  • Withdrawn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 24 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
5898, VALO X 600 Barrier Sleeves Refill
Primary DI / UDI-DI
07350069421845
Basic UDI-DI
++B9764000006K
Unit of Use DI
07350069420848
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
5898
GUDID
VALO X 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