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Epimed International, Inc.

by Epimed International, Inc. 25 variants

Ref 166-2024Model Spring Guide Epidural Catheter, Spirol Guide Epidural Catheter

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number081878802SGECH6 Basic UDI-DI 00818788021250UDI-DIDate29 Jul 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number081878802SGECH6 Basic UDI-DI 00818788021250UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818788021250 UDI-DI Date24 Oct 2017ListedStatusListed GUDID: in commercial distribution

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.

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Epimed International,Inc. EUDAMED
Epimed GUDID
Generic Name
Epidural anaesthesia set, non-medicated
Model / Ref / Catalog
Spring Guide Epidural Catheter, 166-2024, Spirol Guide Epidural Catheter
Primary DI / UDI-DI
00818788021250
Basic UDI-DI
081878802SGECH6, B-00818788021250
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
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Unsafe
Size
Catheter Gauge — 2.7 French
Length — 24 Inch

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

  • 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