Skip to content

Epimed 126-1735

by Epimed International, Inc

Ref 126-1735Model Epidural Introducer Needle

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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number081878802EINL2 Basic UDI-DI 00818788023285UDI-DIDate29 Jul 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number081878802EINL2 Basic UDI-DI 00818788023285UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818788023285 UDI-DI Date23 Jul 2020ListedStatusListed 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

1 recall · FDA

    • Terminated Z-0089-2018 FDA Class II initiated 24 Jul 2017 on shared 510(k) K030562

    Potential for partially incomplete seal of product, impacting sterility.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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 needle, non-threaded
Model / Ref / Catalog
126-1735, Epidural Introducer Needle
Primary DI / UDI-DI
00818788023285
Basic UDI-DI
081878802EINL2, B-00818788023285
510(k) Number
FDA Product Code
BSP
EMDN Code
A01030102 Epidural anaesthesia needles and kits
GMDN Term
Epidural needle, non-threaded
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5150
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Unsafe
Size
Length — 3.5 Inch
Needle Gauge — 17 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K030562)

Show all (10)

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