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SureStay

by Endosys Healthcare India Pvt. Ltd. India EUDAMEDGUDID

Ref SHM-B2P1 / 412FB-50 Product code GADEMDN Z12019099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number089043326SHS0038L Basic UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08904332600711 UDI-DIDate4 Nov 2025ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 25 Oct 2026

Trade Name
SureStay EUDAMED
Mediflex GUDID
Generic Name
Surgical retractor/retraction system blade, single-use
Device Name
Surgical Stays - Skin Hooks
Model / Ref / Catalog
SHM-B2P1 / 412FB-50 EUDAMED
412FB-50 GUDID
Primary DI / UDI-DI
08904332600711
Basic UDI-DI
089043326SHS0038L
FDA Product Code
GAD
EMDN Code
Z12019099 Various instruments for general and multidisciplinary surgery - other
GMDN Term
Surgical retractor/retraction system blade, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4800
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SHM-B2P1 / 412FB-50
GUDID
412FB-50
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IN-MF-000026903
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Endosys Healthcare India Pvt. Ltd

  • SureStay

    Class IIa

  • SureStay

    Class IIa

  • SureStay

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (17)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No

Sources (2)

  • EUDAMED 63326200-d28a-455d-a970-0b441943eca4 61 fields · synced 25 Oct 2026
  • FDA UDI ecc8f1ec-9aa3-469a-95bc-4ff58929d757 34 fields · synced 23 Oct 2026