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Hot/Cold Pearl Packs

by Pharma Lab International Ltd. 7 variants

Ref PEARL-MED

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number366496513101FQ Basic UDI-DI 03615370003000UDI-DIDate4 Aug 2025RegisteredStatusActive

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  • Withdrawn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
Hot/Cold Pearl Packs
Model / Reference
PEARL-MED
Primary DI / UDI-DI
03615370003000
Basic UDI-DI
366496513101FQ
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
HK-MF-000013674
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Pharma Lab International Ltd.

See all devices from Pharma Lab International Ltd. →

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