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Bite Block

by Enter Medical Corporation United States EUDAMED

Ref PN-600-04Model PN-600-01, PN-600-02, PN-600-03, PN-600-04

EMDN G030804

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987210PN600CT Basic UDI-DIDate13 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Bite Block
Model / Reference
PN-600-01, PN-600-02, PN-600-03, PN-600-04
Primary DI / UDI-DI
04719872108733
Basic UDI-DI
471987210PN600CT
EMDN Code
G030804 Gastrointestinal endoscopy and echoendoscopy, bite blocks
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000044216
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Enter Medical Corporation

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED ac8f6f51-972c-4f24-8188-a9f87a079ee2 61 fields · synced 24 Oct 2026