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Tyvek® 12544

by Advanced Sterilization Products Services Inc.

Ref 12544

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0705037A060000000000006Q9 Basic UDI-DI 10705037015924UDI-DIDate16 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10705037015924 UDI-DI Date17 Dec 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  • Withdrawn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
Tyvek® Heat-Seal Pouches with STERRAD™ Chemical Indicator 200 mm x 650 mm (8" x 25½") EUDAMED
Tyvek® GUDID
Generic Name
Chemical/physical sterilization process indicator
Device Name
Tyvek® Pouches and Rolls with STERRAD™ Chemical Indicator
Model / Ref / Catalog
12544
Primary DI / UDI-DI
10705037015924
Basic UDI-DI
0705037A060000000000006Q9
Unit of Use DI
80705037015923
FDA Product Code
FRG, JOJ, KCT
EMDN Code
S01010201 Flat sterilisation pouches, tyvek/plastic film
GMDN Term
Chemical/physical sterilization process indicator
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.6850, 880.2800
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Advanced Sterilization Products, Inc.

See all devices from Advanced Sterilization Products, Inc. →

Properties

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