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Sempermed Syntegra Green SGR750

by Harps USA, Inc.

Ref 827053721Model Sterile, single use, powder free, synthetic polyisoprene, surgical glove, anatomically shaped, green

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9001570PFM-116GR-S-656 Basic UDI-DI 09001570536723UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09001570536723 UDI-DI Date12 Dec 2025ListedStatusListed GUDID: not 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 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  • Withdrawn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
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
827053721 EUDAMED
SGR750 GUDID
Primary DI / UDI-DI
09001570536723
Basic UDI-DI
9001570PFM-116GR-S-656
Unit of Use DI
09001570536082
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
EU 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