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Sempermed Syntegra X

by Ineo Tech Sdn Bhd 8 variants

Ref 3000016264, 52065Model IG1

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
United StatesGUDID listing GUDID Number09551012401152 UDI-DI Date9 Sep 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number955101240MODEL17M Basic UDI-DI Date16 Aug 2024RegisteredStatusActive

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  • Withdrawn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
Sempermed Syntegra X EUDAMED
Biogel® Micro EUDAMED
Biogel® Radiation Protection Micro GUDID
Generic Name
Radiation attenuating polyisoprene surgical/procedural glove
Model / Ref / Catalog
IG1, 3000016264, 52065, Model 1
Primary DI / UDI-DI
09551012401152, 09551012401879
Basic UDI-DI
955101240MODEL17M
FDA Product Code
KGO
EMDN Code
T01010203 Polyisopren surgical gloves
GMDN Term
Radiation attenuating polyisoprene surgical/procedural glove
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4460
EU market of registration
Austria
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
IG1
3000016264
52065
GUDID
Model 1
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
MY-MF-000026701
Authorised representative
Advanced Barrier Solutions SARL FR-AR-000025223

Other devices from Ineo Tech Sdn. Bhd.

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Implantable: No
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No