PTCA Kit

Ref PK190000

PTCA Kit (PK190000) is a Class I device made by ShenZhen Antmed Co., Ltd, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 69457644PK00000010YV), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69457644PK00000010YV Basic UDI-DI 06945764406306UDI-DI	Date4 Nov 2026Registered	StatusActive

Official records

EUDAMED public site Basic UDI-DI 69457644PK00000010YV — open Devices and search for it

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference: PK190000

Primary DI / UDI-DI: 06945764406306
Basic UDI-DI: 69457644PK00000010YV
EMDN code: C010401020199 Ptca dilatation catheters - other

Device class: Class I
EU registration type: Standard device
EU market of registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000029659
Authorised representative: MedNet EC-REP C IIb GmbH DE-AR-000011194

Other devices from ShenZhen Antmed Co., Ltd

Multi-Patient Syringe System

Class IIa
PTCA Kit

Class I
Patient Line

Class I
High Pressure Syringe

Class IIa

See all devices from ShenZhen Antmed Co., Ltd →

Properties

Supplied sterile
Administering medicine

Other properties (12, all answered No)