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Molekur

by Shanghai Coherz Technologies Co., Ltd. 9 variants

Model MOLEKUR ONE MOLEKUR EXPRESS

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06975527188149 UDI-DI Date17 Apr 2026ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number697552718DENTALFOIL01J2 Basic UDI-DI 06975527188149UDI-DIDate15 Dec 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Dental appliance fabrication material, thermoplastic
Device Name
Dental Foil
Model / Reference
MOLEKUR ONE MOLEKUR EXPRESS EUDAMED
Template E Disc-0.50-125 GUDID
Primary DI / UDI-DI
06975527188149
Basic UDI-DI
697552718DENTALFOIL01J2
FDA Product Code
EBH, DYJ
EMDN Code
Q0199 Odontology devices - other
GMDN Term
Dental appliance fabrication material, thermoplastic
Device Class
Class I
Regulation Number
872.3670, 872.5410
EU market of registration
Austria
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MOLEKUR ONE MOLEKUR EXPRESS
GUDID
Template E Disc-0.50-125

Manufacturer details

EUDAMED SRN
CN-MF-000031732
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanghai Coherz Technologies Co., Ltd.

See all devices from Shanghai Coherz Technologies Co., Ltd. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No