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STERIKING® LT-Blueline Heat-Sealable Rolls

by Wipak Oy 6 variants

Ref LTR42

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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 Number6438263ST14010NK Basic UDI-DI 06438263644039UDI-DIDate25 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number06438263644039 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
STERIKING® LT-Blueline Heat-Sealable Rolls EUDAMED
Steriking® GUDID
Generic Name
Sterilization packaging, single-use
Device Name
STERIKING® Pouches and Rolls
Model / Ref / Catalog
LTR42
Primary DI / UDI-DI
06438263644039
Basic UDI-DI
6438263ST14010NK
510(k) Number
FDA Product Code
KCT
EMDN Code
S01020201 Flat sterilisation reels, tyvek/plastic film
GMDN Term
Sterilization packaging, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.6850
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000004496

Other devices from Wipak Oy

See all devices from Wipak Oy →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No