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UltraPrint On-X Teeth Try-in UV

EUDAMED

Class I (EU MDR)

Ref MA.003.655 /MA.004.655Model A1/A2/A3/B1/BLRef MA.003.654 /MA.004.654Ref MA.003.653 /MA.004.653Ref MA.003.652 /MA.004.652

by Guangzhou Heygears Imc.inc

Identity

Trade Name
UltraPrint On-X Teeth Try-in UV EUDAMED
Model / Reference
A1/A2/A3/B1/BL EUDAMED
MA.003.655 /MA.004.655 EUDAMED
MA.003.654 /MA.004.654 EUDAMED
MA.003.653 /MA.004.653 EUDAMED
MA.003.652 /MA.004.652 EUDAMED

Identifiers

Primary DI / UDI-DI
06971437944318 EUDAMED
06971437944301 EUDAMED
06971437944295 EUDAMED
06971437944288 EUDAMED
Basic UDI-DI
697143794ONXTRYIN4C EUDAMED
EMDN Code
Q0102050199,Q010699 EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

UltraPrint On-X Teeth Try-in UV by Guangzhou Heygears Imc.inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Guangzhou Heygears Imc.inc
EUDAMED SRN
CN-MF-000010624
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED c1252b17-064c-4af1-a742-d1d5f403821b 61 fields · synced Jul 23, 2026
  • EUDAMED fb2796fb-b24b-48c0-8bba-1683450bcdcc 61 fields · synced May 17, 2026
  • EUDAMED 9edfcc83-5041-4709-a44f-cd21f6f29368 61 fields · synced May 18, 2026
  • EUDAMED 7ee98dce-44f3-441f-9bd2-a580a9e8283c 61 fields · synced May 19, 2026