Skip to content

Epimed International, Inc.

by Epimed International, Inc. 171 variants

Ref 116-2035Model Nerve Block Needle

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

CE MDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081878802NBNLS Basic UDI-DI 00818788022875UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818788022875 UDI-DI Date23 May 2024ListedStatusListed 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-0088-2018 FDA Class II initiated 24 Jul 2017 on shared 510(k) K041843

    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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Epimed International,Inc. EUDAMED
Epimed GUDID
Generic Name
Peripheral nerve-block blunt needle
Model / Reference
Nerve Block Needle, 116-2035
Primary DI / UDI-DI
00818788022875
Basic UDI-DI
081878802NBNLS, B-00818788022875
510(k) Number
FDA Product Code
BSP
EMDN Code
A019001 Blunt needles
GMDN Term
Peripheral nerve-block blunt needle
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 — 20 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
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
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No