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Amzyme 3 Manual

by Amity Limited 3 variants

Ref J48BMModel VZF

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number506072225AAA0016JX Basic UDI-DI 05060722251604UDI-DIDate15 Feb 2023RegisteredStatusActive

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  • Withdrawn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
Vzf
J48
Model / Reference
J48BM, VZF
Primary DI / UDI-DI
05060722251604
Basic UDI-DI
506072225AAA0016JX, 506072225AAA0003JN
EMDN Code
D0801 Enzymatic detergents for medical devices
Device Class
Class I
EU market of registration
Ireland
Belgium

Manufacturer details

EUDAMED SRN
GB-MF-000023321
Authorised representative
Amity Healthcare EU Ltd. IE-AR-000011613

Related devices

Category: Medical device disinfection agent

Other devices from Amity Limited

See all devices from Amity Limited →

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