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Table Mounted Retractor System

by Mediflex Surgical Product

Ref 69029

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08421021TMRSJ6 Basic UDI-DI 00842102106057UDI-DIDate12 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00842102106057 UDI-DI Date21 Apr 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Table Mounted Retractor System EUDAMED
Bookler Table Mounted Retractor Systems GUDID
Generic Name
Surgical retraction system mounting frame, reusable
Model / Ref / Catalog
69029
Primary DI / UDI-DI
00842102106057
Basic UDI-DI
08421021TMRSJ6
Direct Marketing DI
00842102106057
FDA Product Code
FFO
EMDN Code
L0399 General surgery instruments, reusable - other
GMDN Term
Surgical retraction system mounting frame, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
876.4730
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000026992
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Mediflex Surgical Product

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No