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HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture

by Medos International SARL 6 variants

Ref 280729Model HEALIX ADVANCE PEEK DYNATAPE/DYNACORD

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

CE MDR

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/MDR EUDAMED Number0886705a00084KP Basic UDI-DI 10886705031030UDI-DIDate18 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10886705031030 UDI-DI Date14 Oct 2020ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture EUDAMED
Healix Advance Dynatape Dynacord GUDID
Generic Name
Tendon/ligament bone anchor, non-bioabsorbable
Device Name
HEALIX ADVANCE PEEK Anchor, DYNATAPE Suture, DYNACORD Suture, White/Black, Blue, Black/Blue, White/Blue/Green
Model / Ref / Catalog
HEALIX ADVANCE PEEK DYNATAPE/DYNACORD, 280729
Primary DI / UDI-DI
10886705031030
Basic UDI-DI
0886705a00084KP
510(k) Number
FDA Product Code
HWC, MBI
EMDN Code
P09120102 Anchors, tendon and ligament synthesis
GMDN Term
Tendon/ligament bone anchor, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3040
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000014268
Authorised representative
DePuy Ireland UC IE-AR-000009328

Related devices

Category: Hand-held surgical retractor, reusable

Other devices from Medos International SARL

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Properties

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

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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