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Epimed International, Inc.

by Epimed International, Inc. United States EUDAMEDGUDID

Ref 159-2124Model 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
United StatesGUDID listing GUDID Number00818788023568 UDI-DIDate16 Feb 2021ListedStatusIn 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
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2069-2019 FDA Class II initiated 18 Jun 2019
    • Terminated Z-2068-2019 FDA Class II initiated 18 Jun 2019

    Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.

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, 159-2124, Spirol Guide Epidural Catheter
Primary DI / UDI-DI
00818788023568
Basic UDI-DI
081878802SGECH6, B-00818788023568
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 — 24 Inch
Catheter Gauge — 2.4 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
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (16)
  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (3)

  • EUDAMED af7bc0c8-845e-4f5e-b80f-ca9030281445 61 fields · synced 24 Oct 2026
  • FDA UDI f1b7a81e-26d1-4f94-9fd1-c4f4565979ee 38 fields · synced 30 May 2026
  • EUDAMED 00818788023568|B-00818788023568 61 fields · synced 11 Oct 2026