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Repair Kit Rpk-01

by Medical Components Inc

Ref RPK-01

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00884908105MQ Basic UDI-DI 00884908165722UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884908165722 UDI-DI Date23 Oct 2015ListedStatusListed 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  • Withdrawn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
Medcomp and Jet Medical Repair Kits EUDAMED
Repair Kit GUDID
Generic Name
Vascular catheterization support/maintenance kit, non-medicated
Device Name
Tesio and Chronic Twinline Repair Kits
Model / Reference
RPK-01
Primary DI / UDI-DI
00884908165722 EUDAMED
00884908039856 GUDID
Basic UDI-DI
00884908105MQ
FDA Product Code
NFK
EMDN Code
F9080 Dialysis devices - other accessories
GMDN Term
Vascular catheterization support/maintenance kit, non-medicated
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5540
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00884908165722
GUDID
00884908039856
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Vascular catheterization support/maintenance kit, non-medicated

Other devices from Medical Components Inc

See all devices from Medical Components Inc →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No