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Skater

by Argon Medical Devices, Inc. 12 variants

Ref 700304015, 655506300Model 700304007, 700305015, 700304015, 700304010, 700305007, 700305020, 700405015, 700305010, 655506300, 651506000, 651506300, 651006000, 651006300

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0886333010006XP Basic UDI-DI Date9 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20886333005783 UDI-DI Date12 Jul 2022ListedStatusListed 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.

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  • Withdrawn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
Skater EUDAMED
Skater™ Centesis Catheter GUDID
Generic Name
Abdominal paracentesis needle, single-use
Device Name
Skater Centesis Catheter
Skater Introducer Set
Model / Ref / Catalog
700304007, 700305015, 700304015, 700304010, 700305007, 700305020, 700405015, 700305010, 655506300, 651506000, 651506300, 651006000, 651006300
Primary DI / UDI-DI
20886333005783 EUDAMED
20886333005073 EUDAMED
00886333005789 GUDID
Basic UDI-DI
0886333010006XP, 0886333010014XN
Unit of Use DI
00886333005789, 00886333005079
FDA Product Code
GBQ
EMDN Code
A060204, A0680
GMDN Term
Abdominal paracentesis needle, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4200
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20886333005783
20886333005073
GUDID
00886333005789
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000002324
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • 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
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No