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sempermed syntegra preCision

by HARPS Investment Asia Pte. Ltd. 4 variants

Ref 3000016673Model Sterile, single use, powder free, synthetic polyisoprene, surgical glove, anatomically shaped, cream

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09001570557827 UDI-DIDate21 May 2026ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number9001570PFM-116SC-S-64V Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

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  • Withdrawn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

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
cream EUDAMED
3000016673 EUDAMED
SPR600 GUDID
Primary DI / UDI-DI
09001570557827
Basic UDI-DI
9001570PFM-116SC-S-64V
Unit of Use DI
09001570557810
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

Manufacturer details

EUDAMED SRN
SG-MF-000001645
Authorised representative
HARPS Europe GmbH AT-AR-000040870

Other devices from HARPS Investment Asia Pte. Ltd.

See all devices from HARPS Investment Asia Pte. Ltd. →

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