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Genesys Pressft, Hi-Fi

by Conmed Corporation 4 variants

Ref NB261H, NB211, NB262

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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/MDD EUDAMED NumberB-20845854027896 Basic UDI-DI Date10 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20845854027896 UDI-DI Date17 Apr 2024ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Tendon/ligament bone anchor, bioabsorbable
Device Name
Orthopedic, Implant, Bioabsorbable, Certificate 748717
Model / Ref / Catalog
NB261H, NB211, NB262
Description
GENESYS PressFT 2.6 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
GENESYS PRESSFT 2.6 W/TWO #1 (4 METRIC) HI-FI SUTURES (1 WHITE/BLACK AND 1 WHITE/BLUE)
GENESYS PRESSFT 2.1 W/ONE #2 (5 METRIC) HI-FI SUTURE (1 WHITE/BLACK)
Primary DI / UDI-DI
20845854027896, 10845854027851, 10845854027905
Basic UDI-DI
B-20845854027896, B-10845854027851, B-10845854027905
510(k) Number
FDA Product Code
MAI
EMDN Code
P09120102 Anchors, tendon and ligament synthesis
GMDN Term
Tendon/ligament bone anchor, bioabsorbable
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3030
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Outer Diameter — 2.6 Millimeter
Outer Diameter — 2.1 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000012663
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Hand-held surgical retractor, reusable

Other devices from Conmed Corporation

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No