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45930R

by Thompson Surgical Instruments, Inc.

Ref 45930RModel Thompson Retractor System

45930R is a device classified as Class IIa in the EU and Class I in the US made by Thompson Surgical Instruments, Inc., registered in EUDAMED on 28 Feb 2026 (Basic UDI-DI 008415361TRMR) with CE/MDR certificate 1000286127 valid until 18 Dec 2029 and listed in FDA GUDID since 5 Aug 2020 (UDI-DI 00841536114355), active as of 22 Oct 2026.

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

CE MDR

Valid until

18 Dec 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number008415361TRMR Basic UDI-DI 00841536114355UDI-DIDate28 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841536114355 UDI-DI Date5 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 008415361TRMR registered 28 Feb 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841536114355 listed 5 Aug 2020 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000286127 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    5 Feb 2026
    Expires
    18 Dec 2029
    Reason
    Other

Timeline

4 dated events

  1. Listed FDA GUDID 00841536114355
  2. Certificate issued EUDAMED 1000286127
  3. Registered EUDAMED 008415361TRMR
  4. Certificate expires EUDAMED 1000286127

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  • Withdrawn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
Thompson
Generic name
Surgical retraction system, reusable
Model / reference
Thompson Retractor System, 45930R
Primary DI / UDI-DI
00841536114355
Basic UDI-DI
008415361TRMR
Direct marketing DI
00841536114355
FDA product code
GAD
EMDN code
L99 Surgical instruments, reusable - other
GMDN term
Surgical retraction system, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000013232
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Surgical retraction system, reusable

Similar devices in this category

Other devices filed under SURGICAL INSTRUMENTS, REUSABLE - OTHER.

Other devices from Thompson Surgical Instruments, Inc.

See all devices from Thompson Surgical Instruments, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)