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Mint Fix

by Hans Biomed Corp.

Ref MINT MT 15WC1810

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-18809556171955 Basic UDI-DI 18809556171955UDI-DIDate5 Jan 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number18809556171955 UDI-DI Date23 Mar 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 24 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  • Withdrawn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

Trade Name
Mint Fix EUDAMED
Mint GUDID
Generic Name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Model / Reference
MINT MT 15WC1810
Primary DI / UDI-DI
18809556171955 EUDAMED
08809556174300 GUDID
Basic UDI-DI
B-18809556171955
510(k) Number
FDA Product Code
NEW
EMDN Code
H010101010101 Polydioxanone monofilament with needle for open surgery
GMDN Term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
878.4840
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
18809556171955
GUDID
08809556174300
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000013474
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Hans Biomed Corporation

See all devices from Hans Biomed Corporation →

Properties

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

Other properties (16)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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