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Tyvek® Heat Seal Pouch with STERRAD™ Chemical Indicator 200 mm x 400 mm (8” x 16”)

by Advanced Sterilization Products, Inc.

Ref 42541

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0705037A060000000000006Q9 Basic UDI-DI 10705037068128UDI-DIDate16 Apr 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Tyvek® Pouches and Rolls with STERRAD™ Chemical Indicator
Model / Reference
42541
Primary DI / UDI-DI
10705037068128
Basic UDI-DI
0705037A060000000000006Q9
Unit of Use DI
80705037068127
EMDN Code
S01010201 Flat sterilisation pouches, tyvek/plastic film
Device Class
Class I

Manufacturer details

EUDAMED SRN
US-MF-000008427
Authorised representative
ASP, The Netherlands B.V. NL-AR-000002057

From the manufacturer

Manufacturer's product page: Tyvek® Pouches and Rolls with STERRAD™ Chemical Indicator

Other devices from Advanced Sterilization Products, Inc.

See all devices from Advanced Sterilization Products, Inc. →

Properties

Other properties (13)

  • 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