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Epimed International, Inc.

by Epimed International, Inc. 171 variants

Ref 1911-219Model Nearaxial Catheter Connector

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081878802CathConnectorQW Basic UDI-DI 00818788021533UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00818788021533 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

1 recall · 1 ongoing · FDA

    • Ongoing Z-0508-2025 FDA Class II initiated 16 Oct 2024

    The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

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  • Withdrawn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
Luer/Luer linear connector, single-use
Model / Ref / Catalog
Nearaxial Catheter Connector, 1911-219
Primary DI / UDI-DI
00818788021533
Basic UDI-DI
081878802CathConnectorQW, B-00818788021533
510(k) Number
FDA Product Code
CAZ
EMDN Code
A070199 Adapters and connectors - other
GMDN Term
Luer/Luer linear connector, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5140
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide
MRI Safety
MR Unsafe

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
  • Prescription Use
  • 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
  • Administering Medicine: 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