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Pinel Patient Safety System - Complete Kit in a Bag (#7B)

by Pinel Medical Inc.

Ref 7B

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 Number++M82562482RT Basic UDI-DI ++M825COMPLETEKIT33UDI-DIDate3 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Pinel Medical Patient Safety System
Model / Reference
7B
Primary DI / UDI-DI
++M825COMPLETEKIT33
Basic UDI-DI
++M82562482RT
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CA-MF-000054672
Authorised representative
Advena Limited MT-AR-000000234

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Pinel Medical 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