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Int

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref AS1002

by Shanghai Kindly Medical Instruments Co., Ltd.

Identity

Trade Name
INT FDA UDI
Generic Name
Angiographic syringe FDA UDI
Device Name
Angiography Syringe EUDAMED
10ml, fixed adapter; FDA UDI
Model / Reference
AS1002 EUDAMEDFDA UDI
Description
10ml, fixed adapter; FDA UDI

Identifiers

Primary DI / UDI-DI
06950900920240 EUDAMEDFDA UDI
Basic UDI-DI
69509009CEACSM2 EUDAMED
510(k) Number
K170025 FDA UDI
FDA Product Code
DXT FDA UDI
EMDN Code
C0104020280 INTERVENTIONAL PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
GMDN Term
Angiographic syringe FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.1650 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

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

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

Category: Angiographic syringe

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

Similar devices

Also classified as Angiographic syringe.

Cleared under the same submission

K170025 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shanghai Kindly Medical Instruments Co., Ltd.

Sources (2)

  • FDA UDI 94d036b4-7c4c-461e-8478-feffcab3c05e 34 fields · synced Jul 12, 2026
  • EUDAMED 8f6de8b9-085d-4b0d-aeab-23f07990e20d 61 fields · synced Jun 14, 2026