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Epimed 155-2540

by Epimed International, Inc United States EUDAMEDGUDID

Ref 155-2540Model Spring Guide Epidural Catheter, Spirol Guide Epidural Catheter Product code BSOEMDN N010401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081878802SGECH6 Basic UDI-DIDate29 Jul 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED Number081878802SGECH6 Basic UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818788021106 UDI-DIDate20 Oct 2017ListedStatusIn 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

1 recall · FDA

    • Terminated Z-1276-2021 FDA Class II initiated 1 Feb 2021

    Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Epimed International,Inc. EUDAMED
Epimed GUDID
Generic Name
Epidural anaesthesia set, non-medicated
Model / Ref / Catalog
155-2540, Spring Guide Epidural Catheter, Spirol Guide Epidural Catheter
Primary DI / UDI-DI
00818788021106
Basic UDI-DI
081878802SGECH6, B-00818788021106
510(k) Number
FDA Product Code
BSO
EMDN Code
N010401 Peripheral nervous system catheters and kits
GMDN Term
Epidural anaesthesia set, non-medicated
Device Class
Class IIb EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5120
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Unsafe
Size
Catheter Gauge — 3.2 French
Length — 33.25 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K954584)

Show all (9)

Other devices from Epimed International, Inc

See all devices from Epimed International, Inc →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Administering Medicine
  • Prescription Use
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (3)

  • FDA UDI fe5a38d6-13e3-4f54-9bcc-374068eb8333 38 fields · synced 23 Oct 2026
  • EUDAMED 00818788021106|081878802SGECH6 61 fields · synced 12 Jul 2026
  • EUDAMED 00818788021106|B-00818788021106 61 fields · synced 8 Oct 2026