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INT, SlideCath

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref ACCOBRA25F0065

by Shanghai Kindly Medical Instruments Co., Ltd.

Identity

Trade Name
INT,SlideCath FDA UDI
Generic Name
Angiographic catheter, single-use FDA UDI
Device Name
Angiography Catheter EUDAMED
5F COBRA 2, 65cm FDA UDI
Model / Reference
ACCOBRA25F0065 EUDAMEDFDA UDI
Description
5F COBRA 2, 65cm FDA UDI

Identifiers

Primary DI / UDI-DI
06950900930843 EUDAMEDFDA UDI
Basic UDI-DI
B-06950900930843 EUDAMED
510(k) Number
K201929 FDA UDI
FDA Product Code
DQO FDA UDI
EMDN Code
C0104020101 PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS EUDAMED
GMDN Term
Angiographic catheter, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

INT, SlideCath by Shanghai Kindly Medical Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K201929 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shanghai Kindly Medical Instruments Co., Ltd.

Sources (2)

  • FDA UDI 28fccabc-8f47-4e26-b3b6-ba660d296d7c 34 fields · synced Oct 7, 2026
  • EUDAMED 84f7fa07-5bd8-4ca6-bbce-1168785a444d 61 fields · synced Jul 29, 2026