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R-101

by Pascal Company Inc.

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

Ref 26101

R-101 (26101) is a hand-held dental retractor (EU MDR Class I; FDA Class I; FDA product code EIF, Accessories, Retractor, Dental) made by Pascal Company, Inc., registered in EUDAMED on 7 May 2024 (Basic UDI-DI 03108669001HF) and listed in FDA GUDID since 9 May 2022 (UDI-DI 00310866002170), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number03108669001HF Basic UDI-DI 00310866002170UDI-DIDate7 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00310866002170 UDI-DI Date9 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 03108669001HF registered 7 May 2024 Active
  • FDA GUDID UDI-DI 00310866002170 listed 9 May 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00310866002170
  2. Registered EUDAMED 03108669001HF

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  • Withdrawn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

Trade name
R-101 EUDAMED
Retrax System R-101 Packing Instrument GUDID
Generic name
Hand-held dental retractor
Model / Ref / Catalog
26101
Primary DI / UDI-DI
00310866002170
Basic UDI-DI
03108669001HF
FDA product code
EIF
EMDN code
Q010204 Retraction wires and gingival retractors
GMDN term
Hand-held dental retractor
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00310866002170: EUDAMED states No, FDA GUDID states Yes.

Manufacturer details

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

Related devices

Category: Gingival retraction cord, non-medicated

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 NoEUDAMEDYesGUDID
  • Premarket exempt
Other properties (23, all answered No)