Skip to content

PT-55, Pink

by Pascal Company Inc.

Part of a family of 23 devices: see the family page

Ref 26137

PT-55, Pink (26137) is a medical device (EU MDR Class I; EMDN category retraction wires and gingival retractors) made by Pascal Company, Inc., registered in EUDAMED on 7 May 2024 (Basic UDI-DI 03108669001HF), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number03108669001HF Basic UDI-DI 00310866002729UDI-DIDate7 May 2024RegisteredStatusActive

Official records

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  • Withdrawn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
Packing Instruments
Model / reference
26137
Primary DI / UDI-DI
00310866002729
Basic UDI-DI
03108669001HF
EMDN code
Q010204 Retraction wires and gingival retractors
Device class
Class I
EU registration type
Standard device
EU market of registration
Croatia

Manufacturer details

EUDAMED SRN
US-MF-000032036
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under RETRACTION WIRES AND GINGIVAL RETRACTORS.

Other devices from Pascal Company, Inc.

See all devices from Pascal Company, Inc. →

Properties

  • Sterilise before use
Other properties (13, all answered No)