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Sempermed Syntegra Green SGR600

by Harps USA, Inc. EUDAMEDGUDID

Active European Union

Ref 827053601Model Sterile, single use, powder free, synthetic polyisoprene, surgical glove, anatomically shaped, green

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9001570PFM-116GR-S-656 Basic UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09001570536693 UDI-DIDate12 Dec 2025ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Sempermed Syntegra Green
Generic Name
Polychloroprene surgical glove, non-powdered
Model / Ref / Catalog
Sterile EUDAMED
single use EUDAMED
powder free EUDAMED
synthetic polyisoprene EUDAMED
surgical glove EUDAMED
anatomically shaped EUDAMED
green EUDAMED
827053601 EUDAMED
SGR600 GUDID
Primary DI / UDI-DI
09001570536693
Basic UDI-DI
9001570PFM-116GR-S-656
Unit of Use DI
09001570535962
510(k) Number
FDA Product Code
KGO, LZC
EMDN Code
T01010203 Polyisopren surgical gloves
GMDN Term
Polychloroprene surgical glove, non-powdered
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4460, 880.6250
Market of Registration
Austria
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

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Properties

  • Sterile
  • Single Use
  • Over-the-Counter

Other properties (21)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No