Skip to content

Thermoforming Sheet

by Shanghai Maxflex Medical Technology Co., Ltd. 32 variants

Ref T-ECDA-343-R102-076-N

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697506309TSMUQ Basic UDI-DI 06975063091866UDI-DIDate7 Aug 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  • Withdrawn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
Thermoforming Sheet
Model / Reference
T-ECDA-343-R102-076-N
Primary DI / UDI-DI
06975063091866
Basic UDI-DI
697506309TSMUQ
EMDN Code
Q010499 Orthodontic devices - other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000032435
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai Maxflex Medical Technology Co., Ltd.

See all devices from Shanghai Maxflex Medical Technology Co., 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