PTCA Kit
by Shenzhen Antmed Co., Ltd 3 variants
Ref PK190030
PTCA Kit (PK190030) 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
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69457644PK00000010YV 06945764409116 | Date4 Nov 2026 | StatusActive |
Official records
- EUDAMED public site 69457644PK00000010YV
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- PK190030
- Primary DI / UDI-DI
- 06945764409116
- 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
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