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INT, SlideCath ACPIGS5F1065

by Shanghai Kindly Medical Instruments Co., Ltd.

Ref ACPIGS5F1065Model 4F, 5F, 6F

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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 Number69509009CEACQN Basic UDI-DI 06950900900969UDI-DIDate24 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06950900900969 UDI-DI Date11 Sep 2023ListedStatusListed 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

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
INT,SlideCath
Generic Name
Angiographic catheter, single-use
Device Name
Angiography Catheter
Model / Reference
ACPIGS5F1065, 4F, 5F, 6F
Primary DI / UDI-DI
06950900900969
Basic UDI-DI
69509009CEACQN
510(k) Number
FDA Product Code
DQO
EMDN Code
C0104020101 Panoramic and selective peripheral diagnostic angiography catheters and microcatheters
GMDN Term
Angiographic catheter, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1200
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K201929)

Show all (12)

Other devices from Shanghai Kindly Medical Instruments Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

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