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GT Metabolic Magnet

by GT Metabolic Solutions, Inc.

Ref MAG-04Model MAG-01

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

CE MDR

Valid until

14 Jun 2031

CE MDR certificate

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850054216120 UDI-DI Date30 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0850054216MAGXW Basic UDI-DI 00850054216120UDI-DIDate16 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 845351 Active

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Jun 2026
    Expires
    14 Jun 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
GT Metabolic Magnet EUDAMED
GT Metabolic Magnet - 60mm GUDID
Generic Name
Gastrointestinal anastomosis coupler, non-bioabsorbable
Device Name
GT Metabolic Magnet, 40mm
Model / Reference
MAG-01, MAG-04
Primary DI / UDI-DI
00850054216120
Basic UDI-DI
0850054216MAGXW
510(k) Number
FDA Product Code
SAH
EMDN Code
H0299 Mechanical surgical staplers - other
GMDN Term
Gastrointestinal anastomosis coupler, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4816
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000032479
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from Gt Metabolic Solutions, Inc.

See all devices from Gt Metabolic Solutions, Inc. →

Properties

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

Other properties (19)

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