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MAARC Heat Cure Lab Pack - Clear

by Aadi Med Private Limited

Ref 6501/001Model 6001/XXX, 6002/XXX, 6003/XXX, 6004/XXX

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 Number890611044HC2223VK Basic UDI-DI 08906110441080UDI-DIDate29 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  • Withdrawn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
MAARC Heat Cure Polymer
Model / Reference
6001/XXX, 6002/XXX, 6003/XXX, 6004/XXX, 6501/001
Primary DI / UDI-DI
08906110441080
Basic UDI-DI
890611044HC2223VK
EMDN Code
Q01020605 Temporary dental prostheses
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000020405
Authorised representative
Obelis s.a. BE-AR-000000106

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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