SafeCut

by Shunmei Medical Co., Ltd 36 variants

Ref 635533

Active European Union

CE MDR

Valid until

10 Mar 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

Certifier Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69560144CCBDCKH Basic UDI-DI 06956014455333UDI-DI	Date17 Mar 2026Registered	StatusActive
European Union	CE/MDR	Number1TD-MDR-0061/03/2026/01	Date11 Mar 2026Issued	StatusActive expires 10 Mar 2029

Certificates

1 certificate · EUDAMED

1TD-MDR-0061/03/2026/01 Active

Technical documentation EU MDR

Certifier

Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi 2764

Issued
11 Mar 2026

Expires
10 Mar 2029

Valid from
18 Mar 2026

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Coronary Cutting Balloon Dilatation Catheter
Model / Reference: 635533

Primary DI / UDI-DI: 06956014455333
Basic UDI-DI: 69560144CCBDCKH
EMDN Code: C010401020101 Ptca balloon dilation catheters

Device Class: Class III
EU market of registration: Türkiye

Manufacturer details

EUDAMED SRN: CN-MF-000001160
Authorised representative: Lotus NL B.V. NL-AR-000000121

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Properties

Sterile

Other properties (12)

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