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Epimed International, Inc.

by Epimed International, Inc. United States EUDAMEDGUDID

Ref 165-1936Model Spring Guide Epidural Catheter, Spirol Guide Epidural Catheter Product code BSOEMDN N010401

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number081878802SGECH6 Basic UDI-DIDate29 Jul 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number081878802SGECH6 Basic UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818788021229 UDI-DIDate24 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 AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Completed Z-2313-2021 FDA Class II initiated 28 Dec 2017
    • Completed Z-2312-2021 FDA Class II initiated 28 Dec 2017

    Potential for stylet to protrude from the distal end of the catheter

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Epimed International,Inc. EUDAMED
Epimed GUDID
Generic Name
Epidural anaesthesia set, non-medicated
Model / Ref / Catalog
Spring Guide Epidural Catheter, 165-1936, Spirol Guide Epidural Catheter
Primary DI / UDI-DI
00818788021229
Basic UDI-DI
081878802SGECH6, B-00818788021229
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
Length — 36 Inch
Catheter Gauge — 3.2 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000010774
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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)

  • EUDAMED d1cc7f44-fd3e-4a99-9df4-18768fc39c58 61 fields · synced 23 Oct 2026
  • FDA UDI ad05f1a3-8933-4fad-a23b-cb828f11a5d3 38 fields · synced 30 May 2026
  • EUDAMED 00818788021229|B-00818788021229 61 fields · synced 24 Oct 2026